Side Effects & Recall Lawsuit
DePuy Hip Replacement Recall Lawsuit
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DePuy Hip Replacement Recall Lawsuit
DePuy Pinnacle Hip Replacement Implant Ultamet Recall
Following the DePuy ASR recall, there have been numerous complaints that DePuy Pinnacle hip implant is causing similar problems when used with a metal liner. Patients and doctors demand that, with more than 1,300 adverse event reports filed with the FDA against Pinnacle hip implant, it is high time DePuy Orthopedics issued a recall for the device, which is reported to have a 13 percent failure rate. The device is linked to potential side effects, including severe pain, hip dislocation, hip replacement failure, metal toxicity, and need for a revision surgery in many cases.
The FDA approved the DePuy Pinnacle® Ultamet® metal acetabular inserts in 2001. However, not all Pinnacle hip devices are metal on metal, but the metal bearing surface poses the risk of revision compared to other bearing surfaces, including plastic, polyethylene, ceramic, and polymer. The Pinnacle metal on metal hip replacement system with a femoral head, particularly the one that is more than 32 mm, poses a threat of revision surgery. Though the Pinnacle Ultamet does not have as high a failure rate as ASR implants, a large number of incidences of
metallosis have been associated with it.
What is Metallosis and How Is It Caused?
Metal toxicity is caused by metal ions released from the metal bearing surfaces of the replacement system. As these metal fragments are toxic to the soft tissues adjoining the hip joint, these do not allow the artificial hip to bond with the hip bone, thus posing the risk of loosening and failure of the implant. In many patients, radiologic images show complications, including fluid collections, soft tissue reactions, and pseudotumors, for which surgeons recommend revision surgery, which involves removal and replacement of the implant. Metal toxicity causes high levels of cobalt and chromium in the body, which further risk causing tumors in the body.
As a result of metal toxicity, patients experience inflammation, headache, discomfort, dizziness, lethargy, gastrointestinal problems, muscle and tissue damage, food allergies, and bone fractures. It might also cause heart problems, nerve damage, skin rashes, numbness, depression, confusion, and loss of cognitive and sensory capabilities.
Many surgeons claim that they found widespread damage from metallosis to the soft tissue while they were removing metal on metal implants to replace them with new implants. They found avulsed tendons, cavities containing cloudy fluid under pressure, necrotic soft tissues, and denuded osteonecrotic upper femora. Metal toxicity is known to damage the upper part of the femur and soft tissue, which creates walking problems for the patient because these supporting tissues are of utmost importance for the proper hip movement.
The DePuy CoMpleteTM Acetabular Hip System is designed for patients suffering from hip joint damage from non-inflammatory degenerative joint disease, osteoarthritis, or post-traumatic arthritis, which cause disability and severe pain. However, DePuy has recorded more than 300 complaints of hip failure against Pinnacle® Ultamet® metal acetabular inserts since its introduction six years back. Moreover, the FDA has received more than 1,300 complaints from recipients of DePuy Pinnacle hip replacements complaining of debilitating hip and groin pain, surgeons finding cobalt, chromium particles and signs of metallosis in the patient’s body, and reports of cup dislocation.
Before marketing its metal-on-metal replacement system, DePuy had advertised that these bearing surfaces would last longer, claiming that patients would not have to undergo any revision over a lifetime. However, now many surgeons do not recommending metal-on-metal implants for their patients, seeing the high failure rate. Patients experience severe and unexplained hip pain, loss of mobility, walking and standing problems, cup loosening and dislocation, hip failure, and metal poisoning. Further, if high levels of chromium and cobalt are found in the patient’s blood, revision surgery may also be recommended.
Complications Linked With Revision Surgery
A number of surgeons have complained that there is a fundamental design flaw in the hip implants. They complain that they find difficulty during the secondary procedure because they of lack of bony ingrowth, which is essential to keep the implant in its position. Doctors find the revision surgery more extensive and complicated, as it requires removal of the defective hips and then implantation of new components and the lack of bony ingrowth makes it more complicated.
In reality, DePuy’s Pinnacle never underwent through the clinical trial process, as DePuy Orthopedics exploited a loophole in the FDA regulation 510(k), which allowed it to sell the device the need for conducting any clinical trials. Soon after Pinnacle hip implant has been launched, reports of device failure started surfacing. In 2002 May, a patient registered a complaint with DePuy that he had to undergo a revision surgery due to the disassociation of the liner with the cup. However, DePuy did not take any action and rather closed the investigation, saying “corrective action is not indicated.” Two weeks later, the company received another complaint from a patient who had to undergo secondary surgery to remove and replace the defective device because of the loosening of the acetabular cup. But DePuy again came up with a similar finding that “corrective action is not indicated.”
Earlier Hip Implant Recalls
The FDA is yet to recall the DePuy Pinnacle hip implant despite numerous reports of hip failure, which necessitates revision surgery.
Earlier, DePuy ASR implants were recalled due to a more-than-expected device failure rate. DePuy ASR devices had similar problems, including cup loosening and dislocation, severe pain following the first procedure, walking problems, and need for revision surgery.