On August 29, 2016, Stryker Corporation issued an urgent medical device recall related to its Stryker LFIT Anatomic CoCr V40 series of femoral heads due to “higher than expected complaints of taper lock failure.” These femoral heads are used in a number of the company’s modular hip replacement systems (used in hip replacement procedures) such as the Accolade and others. The recall is for specific lots of certain sizes of femoral heads manufactured prior to 2011. The taper lock is the part of the implant that connects the femoral head to the femoral neck.
Stryker Hip Problems:
Potential hazards as reported by Stryker may include:
- Disassociation of the femoral head from the hip stem
- Fractured hip stem trunnion
- Excessive metallic debris
- Insufficient soft tissue tension
- Noise
- Loss of implant: bone fixation strength
- Excessive wear debris (polymeric)
- Implant construct with a shortened neck length
As also acknowledged by Stryker, these potential hazards may result in one or more of the following potential patient harms:
- User annoyance
- Loss of mobility
- Pain requiring revision
- Inflammatory response
- Adverse local tissue reaction
- Dislocation
- Joint instability
- Revision to alleviate hazardous situation
- Pain associated with implant loosening
- Periprosthetic fracture
- Leg length discrepancy
On September 27, 2016, the Austrian health authorities also issued a “Hazard Alert” due to a higher than expected incidence of taper lock failures of the LFIT Anatomic CoCr V40 femoral heads.
Ongoing Litigation:
Lawsuits have been and continue to be filed by individuals who have suffered harm from the recalled Stryker LFIT Anatomic CoCr V40 femoral heads.
Recently, in a January 13, 2016 petition, plaintiffs asked the Judicial Panel on Multidistrict Litigation (JPML) to create a multidistrict litigation (MDL) docket for the cases. A MDL is a type of legal proceeding that helps federal courts efficiently manage many similar cases filed in many different courts across the U.S. by allowing the temporary transfer of all of the federal civil lawsuits to one or more district courts for pretrial consolidation or coordination. The JPML is a group of federal judges designated by the Chief Justice of the United States, which has the responsibility for determining which cases qualify for MDL treatment, as well as which district court to transfer and consolidate these cases. The transfers are made if the Panel determines that the transfers will result in the convenience of the parties and witnesses and will promote the just and efficient conduct of the cases. (For more information about MDLs and the JPML, contact Borgess Law.) The plaintiffs have asked the panel to transfer pending Stryker LFIT cases to the U.S. District Court for the District of Massachusetts, referencing that three of the lawsuits are already pending there.
Borgess Law will continue to keep you updated on the status of the litigation.
How We Can Help:
If you or someone you provide care for has received a LFIT Anatomic CoCr V40 femoral head as part of a total hip replacement, you should be aware of the recall.
Attorney Pamela A. Borgess, the founder of Borgess Law, LLC, has extensive experience with numerous national high-profile defective medical drug/device cases, including hip implants. Attorney Borgess can help you determine if you have one of the recalled Stryker femoral head hip implants and discuss your legal options, if so. For more information about the Stryker hip recall, the resulting lawsuits, or to discuss a potential claim, contact Borgess Law at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law by submitting an online inquiry. Borgess Law never charges for initial consultations. We welcome any questions you may have.