May 26, 2016 - Far too many people have been affected by the Stryker hip recall which occurred in July 2012; although Stryker alluded to some potential issues at the time of the recall, they declined to elaborate very extensively, or put an exact number on the failure rate of the Rejuvenate and ABGII. Stryker did say the devices had a higher-than-normal failure rate and were prone to fretting and corrosion. Hundreds of adverse event reports went to the FDA, and thousands of patients were forced to undergo Stryker hip revision surgery after suffering from Stryker hip metallosis and/or Stryker hip blood poisoning.
Tissue Necrosis a Possible Side Effect of the Recalled Stryker Implants
Many Stryker patients suffered types of tissue reactions as a possible result of the corrosion found between the tapers and implant components. Rejuvenate or ABGII. Many patients also developed pseudotumors after having an ABGII or Rejuvenate device implanted in their body. A pseudotumor is a (generally) benign, inflammatory mass which develops as a response to absorption of cobalt. When these pseudotumors are removed, in some cases tissue necrosis has been observed.
According to Lawyers and Settlements, a 2013 report in The Journal of Bone and Joint Surgery studied the soft tissues of eleven patients who had their Rejuvenate device removed. All eleven patients showed local soft tissue destruction with visible corrosion at the femoral neck-body junction, indicating serious levels of metallosis. This research indicates that patients who received a Rejuvenate or ABGII modular neck hip stem should be evaluated for necrosis in surrounding tissues. This study indicates that, even in the absence of pseudotumors, certain patient’s reaction to increased levels of cobalt and chromium could be tissue necrosis.
Regular Follow-Up Testing Required
When the devices are removed during Stryker hip revision surgery, there is the potential for surgeons to see fibrotic or thick soft tissues. Some surgeons have noticed the underlying bone having a surface which appears necrotic. This information could make Stryker patients who have not yet suffered any overt ill effects from their Stryker Rejuvenate or ABGII wonder whether there could be things going on in their body they are not yet aware of. Since there is no definitive answer to this question, it is extremely important that anyone with a recalled Stryker device implanted in their body have regular follow-up testing done.
Some patients may experience pain and inflammation when there is some level of tissue necrosis going on, while others may not. Many doctors believe a simple x-ray is not sufficient, advising serial radiographs for all patients with metal hip implants. In particular, any level of osteolysis within the first decade after receiving a recalled Stryker hip warrants further evaluation. It could turn out you are fine, and there is no tissue or bone death, or it could be found that you have some level of necrosis.
Patients with Metal Hip Implants Must Be Proactive
It is your responsibility as a patient to be proactive in guarding your health and ensuring you have all the facts. If you have already undergone Stryker hip revision surgery, you may already be a part of the Stryker hip settlement. If not, you may still be eligible if you have a Stryker case on file. Speak to a Stryker hip lawyer as soon as possible and see your physician for additional testing to determine whether you have experienced any soft tissue necrosis.