Orthopedic joint maker Stryker Orthopaedics is recalling its Rejuvenate Modular and ABG II modular neck hip stems because the parts may fret or corrode at the neck junction, which may cause pain and/or swelling. Some patients may even suffer from blood poisoning and require painful revision surgery to remove and replace their devices.
Blood poisoning from corroding artificial hip implants was thought to be a problem only associated with metal-on-metal hip replacement systems. However, the newly recalled Stryker hip implant is not made from all metal parts, but does have metal components. It is being recalled because it is causing similar problems for patients.
The problem with metal-on-metal hip implants made headlines in 2010 when DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a recall of its ASR Acetabulator hip replacement system. The device was made with all-metal parts, designed to be more durable to traditional ceramic or plastic parts.
However, the devices were failing at a higher than expected rate. Most hip implants last 20 years or more, but the DePuy implant was failing after five years or less.
An investigation found that the loosening, fracturing or dislocating of the artificial hip joint was being aggravated by swelling and inflammation that was linked to bits of metal debris flaking off the device when the metal ball moved within the metal socket. This debris not only may lead to tissue damage around the implant, the metal may also leach into patients’ bloodstreams causing a type of blood poisoning known as metallosis.
The FDA has since ordered all makers of all-metal hip implants to conduct safety studies on their devices and to report any cases of blood poisoning.
Metallosis can cause headaches and fatigue, but the long-term effects are yet to be realized. A recent study conducted by the Imperial College London and Ohio State University concluded that metallosis may also do damage to DNA, which could trigger medical complications including cancer.
Stryker has not said whether patients with the now-recalled Rejuvenate Hip Implant or ABG II products have experienced metallosis, but the company did say that problems associated with the devices may result in adverse tissue reactions manifesting with pain and/or swelling. While the recalled Stryker products are not metal-on-metal joints, the femoral stem and the femoral head ball connection is metal-on-metal.
Attorneys at Beasley Allen Law Firm are currently investigating problems associated with the recalled Stryker implants and any metal-on-metal hip replacement systems.