Class 2 device recall stryker trident constrained liner impactors. Although the company has sought to dismiss a class action lawsuit filed against it on behalf of massachusetts residents with defective trident implants, a federal judge recently ruled that stryker. The left was implanted in april, 2009 and the right in march 2010. The trident ceramic acetabular system orthopaedic surgery. Stryker must face trident hip implant lawsuit massdevice. This recall comes on the heels of a warning from the fda to fix a host of longstanding problems, primarily the failure to function and poor fixation with its hip implant components and in. Please contact your stryker representative if you have questions about the availability of stryker products in your area. Correct placement of the acetabular cup in total hip arthroplasty is a crucial step to achieve a satisfactory result and remains a challenge with freehand techniques. Class 2 device recall stryker trident constrained liner. Stryker trident recall timeline hip replacement lawsuits.
Indeed, malpositioning can induce early loosening, high wear and postoperative dislocation 46. Furthermore, the development of the t2 femoral nailing system offers the competitive advantages of. Trident alumina ceramic inserts gain fixation within the shell by means of. Syk cant slip a personal injury lawsuit filed over its trident hip implant because the case asserts a parallel claim that isnt preempted by federal law, a federal judge in. Books entertainment film and motion picture magazines music publishing. Trident tritanium acetabular system surgical protocol indications painful, disabling joint disease of the hip resulting from. The exeter x3 rimfit cup is a highly crosslinked polyethylene cemented cup with 4 pmma cement spacers and a mini flange design, with xray wire to help easily identify the cup position on an xray. Listing a study does not mean it has been evaluated by the u. The trident acetabular system utilizes the cuttingedge total hip acetabular instrumentation. The surgeon should refer to a specific acetabular components surgical technique for a discussion of acetabular surgical procedures.
Trident ii tritanium acetabular shell outcomes study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The information presented is intended to demonstrate the breadth of stryker product offerings. The trident acetabular system is a twopiece component design that is assembled during. Introducing smartsupply, the convenient recurring delivery option for the products that keep your operatory running. Aug 23, 20 on february 22, 2008, the manufacturer initiated a voluntary stryker trident hip recall of two components in the line, including the trident hemispherical cups and the trident acetabular psl cup, like the one received by plaintiff. The tritanium primary cup stryker orthopaedics, mahwah, nj has been on the.
Trident ii tritanium acetabular shell outcomes study. X3 is a secondgeneration hxlpe developed by stryker orthopedics mahwah, nj and is described in detail by its inventors in chapter 16 section 16. Cup restoris tapered femoral stem, trident pst, trident psl, trident hemispherical, accolade. Stryker must defend massachusetts class action lawsuit. Feel confident you can meet the needs of each patient with the versatility of the trident acetabular shell offerings, all of which can be used with strykers advanced bearing options, like mdm x3, x3 polyethylene, and trident constrained liners.
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. Stryker citation, meridian and accolade all three hip replacement devicesthe citation, meridian and accoladeare actually an assemblage of parts. The stryker trident hip class action lawsuit was filed by raymond chasse, jr. Trident alumina ceramic inserts gain fixation within the shell by means of mating tapers. The supine alignment guide offers a visual reference to estimate cup inclination and anteversion during impaction and is. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Lawsuits against medical device manufacturer stryker continue over its recalled trident hip implant system which has forced injured victims to undergo further costly and painful revision surgery. This system highlights our trident ii tritanium shell, bringing together our. Stryker corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks. Various investigators have demonstrated that conventional freehand positioning can result in a high. Postoperative radiographs demonstrated canted seating of the liner. The ceramic is medicalgrade alumina, which is made from finegrained, extremely hard material. Over the years the company expanded and now markets 57,000 products worldwide. Prnewswire strykers joint replacement division today announced the. Stryker trident hip lawsuit acetabular psl cup recall. After much physical therapy, hip still shifts when bending and rising from seated position. By stryker featuring anthony hedley, douglas roger. The shells come in nohole, cluster hole and multiple hole variants, hemispherical and psl peripheral selflocking or rimfit geometries and are. Trident tritanium acetabular system surgical protocol.
Stryker also produces beds that are designed to fit the unique needs of specialty departments within the acute care environment. Trident alumina ceramic inserts gain fixation within the shell by means of mating. Revision of previous unsuccessful femoral head replacement, cup. Non sterile catalog numbers 21992022, 21992028 and 21992032. This unique locking mechanism helps provide a secure interface between the ceramic or polyethylene insert and the shell.
Trident acetabular cup system from stryker view supplier profile. Trident ii tritanium acetabular shell outcomes study full. Lite plate system anterior surgical technique system overview the lite plate system leverages strykers aviator cervical plate locking mechanism to offer onelevel lumbar plates with a unique duallocking mechanism, high degree of angulation, and simplified instrumentation. The following surgical technique describes a onelevel anterior lumbar interbody fusion alif procedure using the oic al peek spacer with a left sided anterior approach. The information presented in this brochure is intended to demonstrate. The midvastus technique is characterized by a 612cm skin incision medial to the patella from just above the tibial tubercle to just above the patella. The triathlon knee system instrumentation has been developed based on strykers 30year orthopaedic history. Stryker has created a next generation locking nail system, bringing together all the capabilities and benefits of separate antegrade and retrograde nailing systems to create a single, integrated surgical resource for fixation of longbone fractures. Stryker offers a wide variety of acetabular components that are compatible with the reliance femoral component. Stryker must defend massachusetts class action lawsuit over. The remaining steps in this surgical technique are similar in both open and minimally invasive surgical approaches. Strykers ultimate goal is to promote patient lifestyle recovery supported by responsible science. Trident acetabular system surgical protocol stryker rpa. 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 system combines the expertise of orthopaedic and human factors engineers with that of surgeons and o. District court, eastern district of california, according to recent court documents. The first stryker hip recall occurred in 2008, when the company recalled certain components from the trident hip system. The shells come in nohole, cluster hole and multiple hole variants, hemispherical and psl peripheral selflocking or rimfit geometries and. Restoration modular revision hip system calcar conical. This surgical technique is a guide to preparing the acetabulum for the trident acetabular system implants utilizing a single set of acetabular instruments.
The bolt provides a method for repeated attachment and detachment of the cup impactor. The surgical procedures were performed using a lateral hardinge approach in all cases. Please refer to the stryker retractor system surgical technique guides, including luxor, phantom, and. Apr 15, 20 lawsuits against medical device manufacturer stryker continue over its recalled trident hip implant system which has forced injured victims to undergo further costly and painful revision surgery. Many of our primary and revision hip implants are somadesigned for optimal fit and function. The stryker trident hip implant is a hip replacement system designed with ceramiconceramic components. The aim was to achieve 45 degrees inclination and 15 degrees anteversion. I have two stryker trident 54 mm hemispherical shell hips. The stryker trident acetabular shell is a widely implanted uncemented acetabular component that can. Stryker trident hip implant lawsuit lawyer, attorney. Plaintiff mary hazelwood alleges that the device prematurely. Dec 21, 2016 trident ii tritanium acetabular shell outcomes study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Expandable tlif and plif technology surgical technique. Fda warning letter over problems with stryker trident hip. Triden tall poly acetabular system this publication sets forth detailed recommended procedures for using stryker orthopaedics devices and instruments. Stryker trident ii tritanium acetabular shell courtesy of stryker corporation. The cup impactor interfaces with stryker trident and tritanium cups via a modular bolt. Early aseptic loosening of the tritanium primary acetabular.
Apr 21, 2015 stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. General anesthesia is commonly used since it is the most comfortable for the patient and allows immediate postoperative neurological assessment. When the patient moves, a ceramic femoral head pivots inside a ceramic acetabular cup inside the pelvis. Stryker orthopaedics trident constrained liner inserterimpactor tip, 22 mm, 28 mm, and 32 mm. Proper reaming and cup positioning in primary total hip replacement feat. Accuracy of acetabular cup positioning using imageless. Th e restoration ps hip system is compatible only with stryker orthopaedics femoral bearing heads listed in the chart on page 16. What differentiates the mis midvastus incision from other surgical approaches is a small 1. Surgical approach each surgeon should use the surgical approach for total hip arthroplasty with. R3 is an acetabular system with stiktite porous coating, offering multiple sizes and options for hip replacement surgery. The plaintiff claims in her products liability suit that she was harmed by a defective stryker hip replacement system, known as the trident. Ceramic inserts must be used with stryker orthopaedics. The information contained in this document is intended for. Trident acetabular system psl surgical protocol the trident acetabular system utilizes the patented innerchange locking mechanism.
This surgical technique is a guide to preparing the acetabulum for the trident allpoly acetabular system implants utilizing the above acetabular instruments. However, it centralized the handling of all pending and future cases involving these implants filed in the new jersey superior court and assigned them to. For sizing purposes the final exeter x3 rimfit cup used is to be 2mm. Trident acetabular system psl surgical protocol stryker meded. Strykers proprietary tritanium technology, a novel, highly porous. Stryker and the fda had been receiving reports of hip replacement complications with the implant, with patients complaining of popping and squeaking noises, pain, difficulty walking, component breakage, and broken bones. Since 1999, orthopaedic surgeons have chosen strykers trident acetabular system for its effectiveness and track record. On march 31, 2009, the new jersey supreme court did not designate this litigation as a mass tort. The stryker hip implant litigation alleges that stryker failed to conduct adequate testing of the stryker trident psl and the stryker trident hemispherical acetabular cup before allowing doctors to implant these medical devices in patients and failed to warn about the high risk that the components may fail or cause painful or debilitating injuries. Stryker trident hip implant class action merchant law. In her stryker trident hip lawsuit, hazelwood brings counts of manufacturing and design defect, breach of implied. Reaming, trial cup position and final cup position was performed navigated. A stryker trident hip lawsuit that was originally filed in california superior court has been moved to u. On january 22, 2008, a stryker hip replacement recall was ordered for certain trident components manufactured at the cork, ireland facility.
Stryker trident class action lawsuit filed over squeaking. Stryker will endeavor to invent, develop and deliver procedural simplification through innovative technologies that provide greater patient satisfaction and potentially lead to longterm clinical success. District court for the district of massachusetts on september 12. Stryker trident hip implant class action merchant law group llp. All images in this technique guide depict an open tlif procedure for image clarity. The information presented is intended to demonstrate a stryker product or a surgical technique. With smartsupply, you pick the products and well deliver them automatically on the schedule you set. Medical device maker stryker said last week that it will voluntarily recall the hip implant surgery products trident psl and hemispherical acetabular cups.
Stryker launches next generation trident ii acetabular system. The solar total shoulder system was designed to address the most common arthritic disorders affecting the shoulder such as rheumatoid, osteo, and posttraumatic arthritis, avascular necrosis and. The trident acetabular system from stryker is an uncemented acetabular system which includes crossfire polyethylene, x3 polyethylene, alumina ceramic, constrained liners, concentric and eccentric liners. The restoration modular hip system is compatible only. Orthopedic manual surgical instrument product code lph. Stryker orthopaedics offers a wide variety of acetabular components that are compatible with the restoration modular femoral components. Triathlon tritanium metaphyseal cones femoral fixation. Surgical technique 4 patient positioning the lite decompression tubes can be successfully used under local, epidural, spinal or general anesthesia. The oic al peek spacer is indicated for the treatment of degenerative spine disorders, discal and vertebral instability as well as spondylolisthesis and cases of. We are on the forefront of the latest surgical approaches including novel musclesparing surgical approaches to tha and mako total hip replacement. X3 was clinically introduced in 2005 for total hip and knee replacements and is available in the trident and tritanium acetabular cup designs. Stryker trident hip cup used in total hip replacement at cleveland clinic in april 2008, hip dislocated in july 2008 resulting in 4 day hospital stay and 8 weeks of body brace.
Stryker hip replacement models causing complications. Canted seating of the stryker modular dual mobility liner within a. Surgical approach each surgeon should use the surgical approach for total hip arthroplasty which is most. Surgical approach, cup size mm, time interval from primary to revision mo. Stryker citation, meridian and accolade hip replacement.
22 359 422 1213 185 562 179 464 54 1123 825 8 1570 1592 1297 824 228 555 793 1279 532 980 1021 1105 1356 1437 1179 433 18 771 953 180 745 910 959 370 53 1406 199 536 1213 1366 999 596 657 606