Imagine discovering that a medical device meant to improve your quality of life could instead lead to costly complications and health risks.
When Stryker Corp. recalled its hip implants in June 2012, it wasn’t just the recalled devices—it was a wake-up call to their potential dangers. With costs ranging from $190 to $390 million for patient care, corrective surgeries, and litigation, what could this mean for those affected by the recall?
This article explores the Stryker hip recall, delving into its reasons, potential risks, and what you need to know if you’ve been affected. Stay informed as we uncover the details that could impact your health and legal options.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered hip surgery complications after being implanted with the Stryker Rejuvenate or ABG II modular-neck hip devices, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Table Of Contents
- Quick Summary:
- Update: Stryker Moves to Settle Rejuvenate, ABG II Hip Litigation
- Stryker Hip Replacement Complications
- Australian Regulators Warn of Hip Failure with Stryker LFIT V40 Femoral Heads
- Stryker Hip Implant FDA Warning Letter
- FAQs
- Get a Free Stryker Hip Implant Recall Lawsuit Evaluation With Our Lawyers
Quick Summary:
- Stryker Corp.’s hip implant recall in June 2012 is expected to cost between $190 and $390 million, covering patient diagnostics, corrective surgeries, and litigation expenses.
- The recall was initiated due to the risk of corrosion in the Rejuvenate and ABG II modular neck hip systems, which can cause tissue damage, pain, and inflammation.
- The recall affects many patients, leading to numerous lawsuits and concerns over the safety of metal-on-metal hip implants.
Update: Stryker Moves to Settle Rejuvenate, ABG II Hip Litigation
May 16, 2017 – At least 95% of eligible patients have registered for a settlement program to resolve product liability lawsuits filed over injuries alleged from Stryker Rejuvenate and ABG II Modular-Neck hip stems. The company has indicated that it will soon begin paying eligible parties.
Stryker Hip Replacement Complications
The most common Stryker hip replacement complications are linked to metal-on-metal implants like the Stryker Rejuvenate and ABG II modular neck systems. These devices have been associated with severe side effects, including metal poisoning, tissue damage, inflammation, and pain.
Stryker hip replacement complications have been reported to include:
- pain
- swelling
- difficulty walking
- squeaky joints
- faulty components
- plant contamination
- local tissue damage
- high failure rates
- metallosis (the release of tiny metal ions into the bloodstream)
Similar complications have also been reported with other metal-on-metal hip systems, such as the DePuy Acetabular and ASR Hip Resurfacing systems, recalled in July 2010 due to similar issues.
The issue of greatest concern is the potential for elevated metal ions in the bloodstream and the damage that can be caused to the muscles, tendons, soft tissue and bone, said Dr. Mary O’Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida. Soft tissue damage is more critical than bone damage. If the bone is damaged, we can do something. But if the muscle is dead because it has been poisoned by metal ions, we can’t recreate it, she said.
Australian Regulators Warn of Hip Failure with Stryker LFIT V40 Femoral Heads
October 5, 2016 – According to Australia’s Therapeutic Goods Administration (TGA), last week, the agency issued a hazard alert regarding Stryker LFIT Anatomic CoCr V40 femoral heads after the devices linked to numerous reports of taper lock failure [1].
TGA noted that patients and orthopedic surgeons should be concerned about complications in patients implanted with the devices, which may include: loss of mobility, pain, inflammation, adverse tissue reactions, dislocation, broken bones around the implant, and the need for painful revision surge.
Recommended Article: MDL Court Schedules First Conference for Stryker LFIT V40 Litigation
Stryker Hip Implant FDA Warning Letter
As claimed by the U.S. Food & Drug Administration (FDA), in November 2007, the agency sent Stryker Corp. a warning letter regarding complaints it had been receiving about hip joint components made at the company’s Mahwah, New Jersey factory [2].
These complaints included reports of hip joints that did not fit properly, an issue that caused patients to experience adverse side effects such as pain, difficulty walking, and squeaky joints. Several Stryker hip prosthesis recipients even reported that pieces of the components had broken off completely, and others had worn unevenly.
The administration’s warning letter said that deficiencies uncovered at the New Jersey facility had directly contributed to the manufacture of faulty hip replacement devices.
Stryker Inc. has reported survival rates of 91.74% at 12 years in all patients with reoperation as an endpoint. However, its performance in younger patients has not been fully established.
They reviewed survivorship and the clinical and radiographic outcomes of this hip system implanted in 107 patients (130 hips) 50 years old or younger at the time of surgery.
The mean age at surgery was 42 years. The minimum follow-up was 10 years (mean, 12.5 years; range, 10–17 years) with no patients lost to followup.
Twelve hips had been revised. Of these, nine had aseptic loosening of the acetabular component and one cup was revised for focal lysis and pain. One hip was revised for recurrent dislocation and one joint underwent revision for infection. Radiographs demonstrated that 14 (12.8%) of the remaining acetabular prostheses were loose but no femoral components were loose.
According to the National Library of Medicine, survivorship of both stem and cup from all causes was 92.6% at an average of 12.5 years. Survivorship of the stem from all causes was 99% and no stem was revised for aseptic loosening as stated in the 2008 study by Princess Elizabeth Orthopaedic Centre [3].
At Schmidt & Clark, LLP, we urge anyone who has been implanted with a Stryker hip replacement device affected by this recall to act fast, as you may be at more risk than you think.
Stryker hip prosthesis recipients should contact their doctors immediately, even if they haven’t yet experienced adverse side effects. Every person with a Stryker Rejuvenate or ABG II modular-neck faces the potential for long-term serious complications, and right now you’re entitled to treatment and compensation.
FAQs
How can a lawyer assist in a Stryker hip recall lawsuit?
A lawyer can assist by evaluating your case, gathering evidence, filing legal claims, negotiating settlements, and representing you in court. Their expertise ensures you receive fair compensation for your injuries and associated damages.
What should I do if my Stryker hip replacement device is recalled?
If your Stryker hip replacement device is recalled, follow the manufacturer’s recall instructions, which typically involve contacting your healthcare provider for further evaluation and potential removal or replacement of the device. Consult a lawyer if you have experienced complications.
How long do I have to file a Stryker hip recall lawsuit?
The time limit to file a Stryker hip recall lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.
What evidence is needed to support a Stryker hip recall lawsuit?
Evidence needed to support a Stryker hip recall lawsuit includes medical records showing the implantation and complications, expert testimony linking the device to the injuries, and any documentation of additional surgeries or treatments required.
Related Articles:
- Stryker ShapeMatch Lawsuit
- Alaska Stryker LFIT V40 Hip Implant Lawsuit
- Stryker LFIT V40 Lawsuits may be Consolidated into MDL
See all related medical device lawsuits our attorneys covered so far.
Get a Free Stryker Hip Implant Recall Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Stryker Hip Recall Lawsuits. We are handling individual litigation nationwide and are currently accepting new injury cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one suffered hip surgery complications after being implanted with the Stryker Rejuvenate or ABG II modular-neck hip devices, you should contact our law firm immediately. You may be entitled to a settlement by a suit and we can help.
References:
- https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads-used-hip-replacements
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149782
- https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml