In a prospective randomized study 27 patients received securfit ha acetabular components with either securfit or securfit plus ha femoral components stryker orthopaedics, mahwah, nj. Simplified, streamlined and incredibly lightweight. The stryker orthopaedics securfit plus max femoral hip stem complements the stryker orthopaedics securfit max. Jan 24, 2017 if you or a loved one has received a metalonmetal stryker hip replacement, you may be eligible for compensation. All fda hip implant and hip implant component recalls.
The femoral component placed was a stryker securfit ha stryker,kalamazoo,misize6stem. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Howmedica osteonics securfit ha ceramic on ceramic. Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Cocr femoral heads, measuring 28 mm were used and randomization was between crossfire and n2vac inserts. The securfit advanced hip stem is intended for cementless, pressfit application. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. Class 2 device recall guide and kwires for t2 and gamma systems significant stryker. Total hip arthroplasty with the securfit and securfit plus femoral stem design. This study is a prospective, openlabel, postmarket, nonrandomized, multicenter clinical evaluation of the securfit advanced hip stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria. Securfitmax securfitplusmax surgical protocol cuttingedgeadvantage hipinstrumentsystem securfitplusmax securfitmax 127 2 127. District court for the district of minnesota on september.
Securfit max hip stem these devices are modular components of a total hip system. Securfit advanced is based on prior clinically successful designs 12 with refinements to the neck geometry and instrumentation. Stryker hip replacement models causing complications. Stryker medical is a leader in the specialty stretcher products segment, offering more than 30 different types of stretchers customized to fit the needs of acute care and specialty surgical care facilities. Its press fit stems include models from the accolade and secur fit product lines, and its revision components include products from the restoration product line.
Do not disclose or use except as authorized in writing by stryker. Hs1 hs2 omnifit ha secur fit ha secur fit advanced. 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 proximal region of the stem is coated with purefix ha over a commercially pure titanium plasma spray substrate. Stryker corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks. Since this bench top test is free of much of the variability occurring in live surgery, t he following. 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. Securities and exchange commission sec, including its annual report on form 10k, quarterly reports on. Stryker corporation the company or stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. 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. Available in several laminate and base colors, stryker singletop and splittop overbed tables coordinate with any room decor. Securfit max securfit plus max surgical protocol stryker meded. Jan 27, 2017 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.
Accolade ii femoral stem, securfit advanced femoral stem, anato. The evolution of stryker s fit and fill stems 1981. Dual radius external geometry cluster dome screw hole pattern elevated shell rim protects ceramic insert from. The products listed above are ce marked according to the medical directive 9342eec. Securfit max reduced neck geometry fo r increased rom features benefits re duced neck geometry provides an increase of up to 15 rom depending on the combination of securfit max femoral and tr ident acetabular components used.
The rejuvenate femoral stem represents the latest evolution in the omnifit and securfit product lines, which has a successful published clinical history. Stryker securfit and ctaper lfit hip implant lawsuit. The complaint pdf was filed by lawrence anderson and his wife, joan, in the u. The trufit overbed table, which is an awardwinning design, easily slides under beds, stretchers and mobile recliners. 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. This material is the property of stryker orthopaedics. Its pressfit stems include models from the accolade and securfit product lines, and its revision components include products from the restoration product line. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. Aug 01, 2008 read total hip arthroplasty with the secur fit and secur fit plus femoral stem design, the journal of arthroplasty on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. History of the securfit ha femoral stem and ctaper lfit femoral head 8. Please contact your stryker representative if you have questions about the availability of stryker products in your area. View online or download stryker securfit advanced surgical technique. Secur fitm ha ceramic on ceramic bearing system surgica secur fit m ha ceramic on ceramic acetabular shell arc deposited.
While arentz law group maintains joint responsibility most cases are referred. The neckshaft angle of the securfit stem is 2, and that of the highoffset securfit plus stem is 127. The secur fit advanced hip stem is suitable for various surgical approaches. Page 3 securfit advanced femoral hip system the securfit advanced hip stem is intended for cementless, pressfit application.
The information presented is intended to demonstrate the breadth of stryker product offerings. Inflammatory pseudotumor after ceramiconceramic total. The trident system is also used in conjunction with the same pressfit howmedica osteonics omnifit ha hip stems as the abc system. This publication sets forth detailed recommended procedures for using stryker orthopaedics devices and instruments. We are on the forefront of the latest surgical approaches including novel musclesparing surgical approaches to tha and mako total hip replacement. Securfitm ha ceramic on ceramic bearing system surgica securfitm ha ceramic on ceramic acetabular shell arc deposited. 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. Stryker securfit and ctaper lfit hip implant lawsuit filed. The letter advises that stryker has received a higher than expected number of adverse reports involving the recalled femoral heads.
The stryker orthopaedics securfit plus max femoral hip stem complements the securfit max femoral hip system by offering implants with an increased base head offset, a distal sizing matrix, and distal flutes. Stryker was incorporated in michigan in 1946 as the successor company to a business founded in 1941 by dr. Plaintiffs in recalled stryker lfitv40 hip implants request centralized litigation. Many of our primary and revision hip implants are somadesigned for optimal fit and function.
Stryker orthopaedics total hip system labeling update. A brief followup report at 5 to 10 years this report represents a 5 to 10year followup of our. The rejuvenate femoral stem represents the latest evolution in the omnifit and secur fit product lines, which has a successful published clinical history. On november 22, 1995, hoc received fda clearance to sell its securfit ha femoral hip stem securfit in the united states.
The stryker orthopaedics secur fit plus max femoral hip stem complements the stryker orthopaedics secur fit max femoral hip system by offering implants with an increased base head offset, a distal. The securfit max femoral hip stem has been built on more than a decade of experience. Our flagship fit and fill femoral stem based on a clinically successful design with modern somadesigned refinements. Stryker also sells numerous femoral components, including pressfit stems, cemented stems and revision components. Securfit max stem combined with the trident ceramic acetabular system positioned at 45 abduction and 20 anteversion, achieves more rom than that. Stryker does not offer medical advice, and we recommend healthcare personnel always undergo training prior to using any product on a patient. Howmedica osteonics securfit ha ceramic on ceramic bearing.
Stryker, a leading orthopaedic surgeon and the inventor of several orthopaedic products. Total hip arthroplasty with the securfit and securfit plus. Request pdf total hip arthroplasty with the securfit and securfit plus femoral stem design. Page 3 secur fit advanced femoral hip system the secur fit advanced hip stem is intended for cementless, press fit application. Securfit max securfit plus max 127 surgical protocol. Securfit plus max stems address the more complicated issues of implant fit and fixation. Stryker also sells numerous femoral components, including press fit stems, cemented stems and revision components. Cocr femoral heads, measuring 28 mm were used and randomization.
Trufit overbed tables stryker patient care united states. District court for the district of minnesota on september, indicating that the stryker securfit and ctaper. The stem is designed for use with stryker v40 femoral heads and. Impact load test model for femoral pressfit design.
Stryker securfit advanced surgical technique pdf download. Novel method for ensuring leg length in total hip arthroplasty. Secur fit max hip stem these devices are modular components of a total hip system. The secur fit advanced hip stem is intended for cementless, press fit application. The securfit is a tapered nonporous coated femoral stem manufactured from a ti6al4v substrate material with a coating consisting of. K953268 class 2 device recall dual taper wedge pressed fit femoral component stelkast co 2. The patients postoperative one or more of the authors of this paper have disclosed potential or pertinent con. Securfit ha with collar, omnifit ha, omnifit eon, omnifit hfx, omnifit normalized, odc fx, and odc hip stem. Cpti coating nominal 50 micron thick ha coating with over 10 years clinical experience normalized. The estimated number of stryker lfit v40 femoral heads that have been implanted into patients is. Read total hip arthroplasty with the securfit and securfit plus femoral stem design, the journal of arthroplasty on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips.
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