Highly crosslinked polyethylene demonstrates 8090% wear reduction by hip simulator testing, however clinical data on this new. Cpti coating nominal 50 micron thick ha coating with over 10 years clinical experience normalized. Inflammatory pseudotumor after ceramiconceramic total hip. Stryker securfit advanced surgical technique pdf download. Jan 24, 2017 by emily cox washington, dc stryker hip replacement lawsuit plaintiffs seeking damages related to certain lfit anatomic cocr femoral heads are requesting to have all such federal claims centralized in the massachusetts u. The patients postoperative one or more of the authors of this paper have disclosed potential or pertinent con. The complaint pdf was filed by lawrence anderson and his wife, joan, in the u. We have 1 stryker secur fit advanced manual available for free pdf download. The rejuvenate femoral stem represents the latest evolution in the omnifit and secur fit product lines, which has a successful published clinical history. The cuttingedge femoral instrumentation prepares the femur for the following femoral implants. Stryker also produces beds that are designed to fit the unique needs of specialty departments within the acute care environment.
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. The femoral component placed was a stryker securfit ha stryker,kalamazoo,misize6stem. Stryker also sells numerous femoral components, including pressfit stems, cemented stems and revision components. On november 22, 1995, hoc received fda clearance to sell its securfit ha femoral hip stem securfit in the united states. We have 1 stryker securfit advanced manual available for free pdf download. Securfit max securfit plus max surgical protocol stryker meded. Sep 21, 2018 the complaint pdf was filed by lawrence anderson and his wife, joan, in the u. This gives caregivers the ability to help provide advanced fall prevention, asset managementand documentation from the bedside. Securfitmax securfitplusmax surgical protocol cuttingedgeadvantage. The trufit overbed table, which is an awardwinning design, easily slides under beds, stretchers and mobile recliners.
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. Most received an omnifit stem stryker orthopaedics, mahwah, nj unless bone quality was poor, in which case they received an eon cemented stem stryker orthopaedics, mahwah, nj. Line extension to the secuffit and securfit plus max jul 1. View and download stryker secur fit advanced surgical technique online. Accolade ii femoral stem, securfit advanced femoral stem, anato. The securfit is a tapered nonporous coated femoral stem manufactured from a ti6al4v substrate material with a coating consisting of. Securfitmax securfitplusmax surgical protocol cuttingedgeadvantage hipinstrumentsystem securfitplusmax securfitmax 127 2 127. In addition, the securfit plus has 2 available distal stem diameters for each body size, as well distal flutes to enhance rotational stability and a. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. Total hip arthroplasty with the securfit and securfit plus.
Available in several laminate and base colors, stryker singletop and splittop overbed tables coordinate with any room decor. Simultaneous hip headstem taper junction measurements of electrochemical corrosion and micromotion. The proximal region of the stem is coated with purefix ha over a commercially pure titanium plasma spray substrate. Line extension to the securfit and securfit plus max hip stem special 510k premarket notification device modification this securfit max and the securfit tm plus max hip stems were cleared for use with metal and alumina ceramic heads. Do not disclose or use except as authorized in writing by stryker. This material is the property of stryker orthopaedics. The securfit advanced hip stem is intended for cementless, pressfit application. Stryker hip implants document library, stryker lawyer. Published studies demonstrate clinical performance and survivorship of more than 15 years with omnifit ha 1 and up to 10 years with securfit ha and securfit plus. 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. Listing a study does not mean it has been evaluated by the u.
In addition, the securfit plus has 2 available distal stem diameters for each body size, as well distal flutes to enhance rotational stability and a distal trislot design for increased flexibility of the stem tip. Cocr femoral heads, measuring 28 mm were used and randomization was between crossfire and n2vac inserts. 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. The success rate of the securfit advanced femoral stem, defined as absence of stem revision for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years postoperative with a noninferiority margin of 2. Strykers obligation under this warranty is expressly limited to supplying replacement parts and labor for, or.
Stryker securfit and ctaper lfit hip implant lawsuit. Stryker medical division, a division of stryker corporation, warrants to the original purchaser that its products should be free from defects in material and workmanship for a period of one 1 year after date of delivery. Show all bone void fillers external fixation nailing plating screws shoulder. The health canada medical device recall listing dated 52812, for the stryker rejuvenate modular hip system, due to the risk of corrosion andor fretting at the modular neck. Total hip arthroplasty with the securfit and securfit. Howmedica osteonics securfit ha ceramic on ceramic. Securfit advanced incorporates the signature body geometry and normalizations of omnifit and secur fit. Thisisatitaniumstemwitha hydroxyapatite proximal coating. To evaluate the success rate of cementless primary thr with the rejuvenate modular hip system as compared to the securfit ha monolithic femoral hip stem, through absence. Securfitm ha ceramic on ceramic bearing system surgica securfitm ha ceramic on ceramic acetabular shell arc deposited. 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. The estimated number of stryker lfit v40 femoral heads that have been implanted into patients is in excess of 100,000. Aug 07, 20 secur fit advanced outcomes study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Securfit max stem combined with the trident ceramic acetabular system positioned at 45 abduction and 20 anteversion, achieves more rom than that.
Additional indication specific to use of securfit advanced hip. Inflammatory pseudotumor after ceramiconceramic total. Simultaneous hip headstem taper junction measurements. We offer marketleading hip replacement implants for total hip arthroplasty including our primary and revision portfolios designed to offer you a wide variety of implants, instrumentation and musclesparing surgical approach options. Stryker also sells numerous femoral components, including press fit stems, cemented stems and revision components. This submission adds the use of a ctaper biolox delta ceramic. The information presented is intended to demonstrate a stryker product. Our trauma and extremities portfolio offers you marketleading implants for the treatment of long and small bone fractures, as well as extremity joint replacements. Raja, ahmad faizan, mayur thakore, kevor tenhuisen. Securfit plus max is not available in 2 neck angle. Rejuvenate total hip system surgical protocol florida stryker hip. Stryker orthopaedics total hip system labeling update. Securfit ha with collar, omnifit ha, omnifit eon, omnifit hfx, omnifit normalized, odc fx, and odc hip stem. Stryker lfit femoral heads another defective hip recall from stryker.
The securfit max femoral hip stem has been built on more than a decade of experience. Laura scholl, viswanathan swaminathan, reginald lee, lokesh k. The rejuvenate femoral stem represents the latest evolution in the omnifit and securfit product lines, which has a successful published clinical history. History of the securfit ha femoral stem and ctaper lfit femoral head 8. Secur fit advanced medical equipment pdf manual download. 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. Stryker securfit and ctaper lfit hip implant lawsuit filed. Secur fitm ha ceramic on ceramic bearing system surgica secur fit m ha ceramic on ceramic acetabular shell arc deposited. The stryker orthopaedics securfit plus max femoral hip stem complements the stryker orthopaedics securfit max. Total hip arthroplasty with the securfit and securfit plus femoral stem design. Steerlock helps maximize cot mobility control by locking the headend casters into a straight position preventing cot drift and enhancing its turning precision. 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. Its pressfit stems include models from the accolade and securfit product lines, and its revision components include products from the.
The securfit advanced hip stem is suitable for various surgical approaches. Preoperative planning aids in the selection of the appropriate implant style and size for the patients hip pathology. The stryker family of hip replacement implants enable the surgeon to match each patient with an appropriate implant using a single set of instruments. Sales growth in several hip systems, including accolade, x3 polyethylene and abg ii, in europe and securfit in japan and the pacific region also contributed to the companys constant currency sales growth in 2008. 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. 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. The letter advises that stryker has received a higher than expected number of adverse reports involving the recalled femoral heads. Published studies demonstrate clinical performance and survivorship of more than 15 years with omnifit ha 1 and up to 10 years with secur fit ha and secur fit plus. Trufit overbed tables stryker patient care united states. This report represents a 5 to 10year followup of our initial 2 to 5year data with this proximally hydroxyapatitecoated stem design secur fit, stryker orthopaedics, mahwah, nj.
This publication sets forth detailed recommended procedures for using stryker orthopaedics devices and instruments. Securfit max securfit plus max 127 surgical protocol. Strykers safest, most advanced manual cot fastener. District court for the district of minnesota on september, indicating that the stryker securfit and ctaper. Broach and neck trial sizing optional step calcar planer leaving the final broach seated in the femoral canal figure 6b, gently guide the female bushing over the broach trunnion. The secur fit advanced hip stem is intended for cementless, press fit application. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. 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. 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. All patients received securfit acetabular components. Line extension to the secuffit and securfit plus max jul.
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. Stems with compatible howmedica osteonics constrained liners. The neckshaft angle of the securfit stem is 2, and that of the highoffset securfit plus stem is 127. Another recall announcement was made by stryker orthopaedics in august of 2016 regarding the companys line of lfit v40 femoral heads manufactured before 2011.
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. The rejuvenate femoral stem represents the latest evolution in the omnifit and. Securfit advanced incorporates the signature body geometry and normalizations of omnifit and securfit. 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. Howmedica osteonics securfit ha ceramic on ceramic bearing. Judicial panel on multidistrict litigation, involves at least. The implant is designed to replace the function of a healthy knee. 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. The secur fit advanced hip stem is suitable for various surgical approaches.
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