Jan 24, 2017 according to the motion, the prosthetic hip used in total hip replacement surgery generally consists of three components a femoral stem, a femoral head or ball, and an acetabular cup with liner. Introduce the stem into the femoral canal axially with a manual. Medical equipment stryker securfit advanced surgical technique. The stem design performed exceedingly well over the course of this study. The rejuvenate femoral stem represents the latest evolution in the omnifit and secur fit product lines, which has a successful published clinical history. If a securfit plus max stem is selected, the size of the. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. Reference therapy securfit ha monolithic femoral hip stem ancillary devices stryker acetabular components and femoral bearing heads must be used according to this study protocol. The package inserts for all unsterile components of the pelvis system.
It represents the next generation omnifit ha stem, which was established with more than 15 years of clinical success, and based on an effective stem geometry combined with stryker s proprietary purefix hydroxylapatite formula. The proximal region of the stem is coated with purefix ha over a commercially pure titanium plasma spray substrate. The securfit stem has 2 neckshaft angle, whereas the securfit plus stem has a 127 neckshaft angle. Rejuvenate modular hip system outcomes study clinicaltrials. Biomet, summit depuy synthes, and securfit ha stryker. Order of court designating multicounty litigation in new jersey. Page 2 knee system scorpio ts trial cutting guide surgical protocol acknowledgements introduction stryker orthopaedics would like to thank this surgical protocol is a supplement dr. Cylindrical reaming for securfit plus max only cylindrically reaming prepares the femoral canal to fit with the distal portion of the securfit plus max prosthesis. The stryker family of hip replacement implants enable the surgeon to match each patient with an appropriate implant using a single set of instruments. The stryker orthopaedics securfit plus max femoral hip stem complements the stryker orthopaedics securfit max femoral hip system by offering implants with an increased base head offset, a distal. The implant is designed to replace the function of a healthy knee. Short stems have lower load at failure than doublewedged stems in. Uncemented hips our uncemented, pressfit femoral stems give surgeons more technological options for.
Jan 27, 2017 seperation of the femoral head from the hip stem. Stryker trident or tritanium primary acetabular shells, with or without screw fixation, as well as. Securfit max 127 and 2 neck an g les available tapered distal stem nor malizations co mpatible with stryker alumina and cobalt chrome ctaper femoral heads ar cdeposited cp titanium orthopaedics minimizing neck geometry, maximizing range of motion cutting edge advantage hip instrument system tr ident ceramic ace tabular. Two noncemented pressfit stems manufactured by stryker orthopaedics mahwah, nj were chosen for comparison. The lfit low friction ion treatment v40 femoral head is compatible with many different models of commercially available stryker femoral stems including the accolade tmzf and secur fit max. My orthopedic surgeon put in a strykersecurefit stem with adm cup. The estimated number of stryker lfit v40 femoral heads that have been implanted into patients is. The accolade femoral stem from stryker is an uncemented, proximally coated, collarless femoral component manufactured from strykers proprietary beta titanium alloy, tmzf. The indications for use for total hip arthroplasty with stems include. Pdf inflammatory pseudotumor after ceramiconceramic. Accolade stem than the securfit stem for both surgically impacted and droptower impacted stems. The secur fit advanced hip stem is intended for cementless, press fit application. If a securfit plus max stem is selected, the size of the cylin. The smaller femoral stem sizes 4, 5, 6 have a 25mm base neck length, which increases by 5 mm in length every 2 femoral sizes, with the largest sizes having a 40mm base neck length.
Rejuvenate total hip system surgical protocol stryker hip implant. The information presented is intended to demonstrate the breadth of stryker product offerings. Ab this report represents a 5 to 10year followup of our initial 2 to 5year data with this proximally hydroxyapatitecoated stem design securfit, stryker orthopaedics, mahwah, nj. Stryker says the lfit anatomic cocr femoral heads are compatible with accolade tmzf, securfit max, citation tmzf, hipstar, and most commercially available stryker femoral hip stems. Having a highoffset option aids the surgeon in proper leg length management. If a securfit plus max stem is selected, the size of the cylindrical portion of the stem is determined from preoperative templating and is confirmed intraoperatively or. Accolade ii femoral stem, securfit advanced femoral stem, anato femoral stem. In clinical settings, the type 2 stem shows a decreased fracture risk compared with the type 6 stem consistently in a number of studies. A surgeon must always refer to the package insert, product label andor instructions for use before using any stryker product.
Abg ii modular extraction protocol stryker corporation. Stryker hip implants document library, stryker lawyer. Total hip arthroplasty with the securfit and securfit. Products may not be available in all markets because product availability is subject to the. Its pressfit stems include models from the accolade and securfit. Optimize your capital investment with a stryker procare service solution, which provides the highest standard of service and support for your facilitys needs. Securfit product lines, which has a successful published clinical history. Inflammatory pseudotumor after ceramiconceramic total hip arthroplasty. The estimated number of stryker lfit v40 femoral heads that have been implanted into patients is in excess of 100,000. The femoral component placed was a stryker securfit ha stryker, kalamazoo, mi size 6 stem. Page 3 securfit advanced femoral hip system the securfit advanced hip stem is intended for cementless, pressfit application.
The cuttingedge femoral instrumentation prepares the femur for the following femoral implants. Stryker issues voluntary recall on accolade hip products. This unique locking mechanism helps provide a secure interface between the ceramic or polyethylene insert and the shell. Surgeon education programs are offered by stryker on a local and regional basis. The stryker cmf customized implant is designed individually for each patient to correct trauma andor defects in the maxillofacial or craniofacial bone. Rejuvenate, abg ii, accolade, securfit, and restoration liners. The arm is secured in place by tightening the threaded locking knob. The securfit advanced hip stem is intended for cementless, pressfit application. Lockrite, pioneer, positionpro, premier, prime series, prime tc, prime x, procare, protocol reminders, secure, skoocher, sheargel, surgistool, symmetry, trufit, wallsaver, xprt. One titanium screw was placed for additional fixation of the cup. Short stems have lower load at failure than doublewedged. Securfit ha with collar, omnifit ha, omnifit eon, omnifit hfx, omnifit normalized, odc fx, and odc hip stem. Masini for his help in developing the to the scorpio total stabilizer revision scorpio trial cutting guide.
Stryker hip recall letters and metal blood testing lawsuits. The stem is designed for use with stryker v40 femoral heads and. Inflammatory pseudotumor after ceramiconceramic total hip. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. The securfit advanced system offers two neck angles 127 degrees and 2 degrees which allows flexibility in adjusting offset intraoperatively. Each surgeon should use the surgical approach for total hip arthroplasty. Surgical technique 4 patient positioning the lite decompression tubes can be successfully used under local, epidural, spinal or general anesthesia. Trident alumina ceramic inserts gain fixation within the shell by means of mating tapers. The securfit advanced hip stem is suitable for various surgical approaches.
While arentz law group maintains joint responsibility most cases are referred. He stated that the xrays looked fine but ordered a bone scan. Mar 02, 2017 stryker says the lfit anatomic cocr femoral heads are compatible with accolade tmzf, securfit max, citation tmzf, hipstar, and most commercially available stryker femoral hip stems. Hip replacement has come a long way in the past decades. Pdf inflammatory pseudotumor after ceramiconceramic total. Secur fit advanced instrumentation has been designed to make surgical procedures efficient and reproducible. General anesthesia is commonly used since it is the most comfortable for the patient and allows immediate postoperative neurological assessment. It represents the next generation omnifit ha stem, which was established with more than 15 years of clinical. Total hip arthroplasty with the securfit and securfit plus. Trident acetabular system psl surgical protocol the trident acetabular system utilizes the patented innerchange locking mechanism. Stryker issues voluntary recall on accolade hip products new jersey product liability attorneys help clients hurt by dangerous medical devices. We are on the forefront of the latest surgical approaches including novel musclesparing surgical approaches to tha and mako total hip replacement. According to strykers marketing materials, the lfit anatomic cocr femoral heads are compatible with accolade tmzf, securfit max, citation. The surgistools customizable seat configurations with fully adjustable backrest and armrests provide optimal support to meet the surgeons specific positioning preferences.
Secur fit advanced medical equipment pdf manual download. The stryker cmf customized implants are manufactured. Epidemiology of dislocation following direct anterior total hip arthroplasty. Patient requires revision surgery of a previously implanted total hip. Inflammatory pseudotumor after ceramiconceramic total. Many individuals with an artificial hip implant are now receiving stryker hip recall letters or notices from their doctors recommending that they undergo metal blood testing, due to a higherthanexpected rate of problems with certain components used during their original surgery, which may cause. The femoral com ponent place d was a stryker securfit ha. Place the ctaper trial head onto the stem neck taper and reduce the hip to verify that. Stryker orthopaedics total hip systems labeling update. Stryker orthopaedics clinical study protocol version 1.
Top 10 things all stryker hip implant patients need. Total hip arthroplasty with the securfit and securfit plus femoral. Nov 30, 2016 many individuals with an artificial hip implant are now receiving stryker hip recall letters or notices from their doctors recommending that they undergo metal blood testing, due to a higherthanexpected rate of problems with certain components used during their original surgery, which may cause. On may 22, 2018, stryker orthopedics issued a product safety notification related to the companys lfit anatomic cocr v40 femoral heads. Strykers tritanium hip implants, which can loosen and require surgical repair.
Proximal femoral strain patterns during femoral component insertion and initial implant stability with two different stem designs. This study provides the surgeon with information on stem properties, especially in the early phase. Seperation of the femoral head from the hip stem hip stem fractures metallic debris causing toxicity. These benefits or support were received from stryker orthopaedics, mahwah, nj. Use the stem impactor to push the stem back out of the femur or hit the plate to extract the stem. During total knee replacement which is also called total knee arthroplasty, your surgeon removes the damaged surfaces of the knee joint and replaces them with metal and plastic components referred to as the prosthesis or implant. Aug 07, 20 this study is a prospective, openlabel, postmarket, nonrandomized, multicenter clinical evaluation of the secur fit advanced hip stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria. The ceramic liner is backed with a titanium alloy that is press fit into the titanium acetabular cup. Having a highoffset option aids the surgeon in proper leg length. Superior pedal access and a stable, yet mobile, design combine to facilitate clinical performance. Efforts to improve cementless femoral stems in tha. The information presented is intended to demonstrate the breadth of stryker product. Stryker announced a new voluntary recall involving certain femoral heads that are used in total hip replacement procedures. The secur fit max femoral hip stem has been built on more than a decade of experience.
Securfit advanced instrumentation has been designed to make surgical. Thank you for taking a moment to read this protocol. Cementless primary hip surgery in cases of noninflammatory. The lfit low friction ion treatment v40 femoral head is compatible with many different models of commercially available stryker femoral stems including the accolade tmzf and securfit max. See package insert l22000007 for a complete list of potential adverse effects, contradistinctions, warnings and precautions. Data from securfit ha monolithic femoral stem cases that are. Securfit max securfit plus max surgical protocol stryker meded. Securfit max hip stem these devices are modular components of a total hip system. During hip replacement surgery, the femoral head is supposed to lock in place. Securfit advanced is based on prior clinically successful designs 12 with refinements to the neck geometry and instrumentation.
Many of our primary and revision hip implants are somadesigned for optimal fit and function. A neutral offset adapter may be used initially to construct the trial cutting guide assembly until. The complexity of femoral and acetabular anatomy and restoring anatomic center of hip rotation in crowe type iv developmental dysplasia of the hip ddh complicates standard reconstruction. Surgistool surgical seating patient handling stryker. Proximal femoral strain patterns during femoral component. I had pain since the surgery and just thought it was normal. Stryker securfit advanced surgical technique pdf download. Our flagship fit and fill femoral stem based on a clinically successful design with. On august 29, 2016, stryker sent an urgent medical device recall notification letter to surgeons that have implanted or reported problems with certain stryker lfit v40 femoral heads made before 2011. By b6 2012, i told my surgeon something was not right. An order by the supreme court of new jersey, designating multicounty litigation for all state court cases involving the stryker rejuvenate hip stem and the abg ii modular hip stem components. Tmzf has a modulus of elasticity closer to that of bone than ti6al4v alloy. This is a titanium stem with a hydroxyapatite proximal coating.
Stryker safety notification for certain femoral heads. The following parameters should be determined using. Ream until the groove on the bossoffset reamer lines up with the planned tria thlo nts kne esystem surgical protocol. Plaintiffs in recalled stryker lfitv40 hip implants request centralized litigation. Securfit advanced medical equipment pdf manual download.
Securfit max securfit plus max minimizing neck geometry, maximizing range of motion reduced neck of secur fit max yields greater rom dashed line indicates secur fit original geometry ap view neck cross section femoral hip stems 325 corporate drive mahwah, nj 07430 t. Secur fit max hip stem these devices are modular components of a total hip system. Surgeons supply stryker with a patient ct scan and the implant is designed to fit the exact patient needs. Wright, phd published in a 20 edition of the journal of bone and joint surgery, incorporated. The femoral component placed was a stryker secur fit ha stryker, kalamazoo, mi size 6 stem. The quality of the ct or cbct scan is the most important. This publication sets forth detailed recommended procedures for using stryker orthopaedics devices and instruments. Stryker hip replacement models causing complications. Craniomaxillofacial stryker cmf customized implant pmma. The company said it received a higher than expected number of complaints documenting femoral headhip stem dissociation for certain sizes of lfit heads manufactured prior to march 4, 2011. The securfit max femoral hip stem has been built on more than a decade of experience. The secur fit advanced hip stem is suitable for various surgical approaches. The rejuvenate femoral stem represents the latest evolution in the omnifit and. The aim of this study is to evaluate surgical techniques and clinical outcomes of subtrochanteric transverse shortening osteotomy with the use of cementless rectangular crosssection femoral.
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