Pain, gait changes, revision surgery and metallosis are all potential problems people may face following hip replacement surgery with metal on metal hip prosthetics including certain specific models of Stryker Hip implants some of which are now subject of a Stryker Hip recall. On July 6, 2012 The Food and Drug Administration (FDA) announced “Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.” Stryker Hip Recall lawsuits have been initiated against the manufacturer by Stryker Hip lawyers and more are expected follow as a result of the most recent Stryker Hip Recall.
July 2012 Stryker Hip Recall not the First
The July, 2012 Stryker Hip recall was not the first Stryker Hip recall for Stryker Orthopaedics Corp., nor was it the first warning received by Stryker from the FDA with regards to their prosthetics. In 2008 a Stryker Hip recall was issued involving the Trident Acetabular PSL Cup and the Trident Hemispherical Cup. The company responded to the recall by defending their manufacturing process and products. Prior to the 2008 Stryker Hip recall, Stryker Orthopaedics Corp received a Warning Letter from the Food and Drug Administration’s (FDA) Inspections, Compliance, Enforcement and Criminal Investigations division. That letter was sent on November 28, 2007. Typically, events such as these will alert the public to a problem they were not previously aware of.
The specific products involved in the first and second Stryker Hip recall are the Trident Acetabular PSL Cup and the Trident Hemispherical Cup and Rejuvenate and ABG II modular-neck stems. As the metal joints move with the patient’s body they can begin to loosen. Patients may hear noises such as a squeaking sound. Some patients report they can feel the prosthetic slipping as they try to stand or walk. Pain can become intense and may completely immobilize the patient. Stryker hip revision surgery (removal of the original implant followed by implantation of another hip prosthetic) may be necessary. Historically, recovery from a revision surgery is more difficult than is recovery from the initial operation. The medical expenses, disruption of life, inability to work as well as pain and suffering often prompt potential victims to seek possible financial compensation through a Stryker Hip lawsuit.
What is metallosis? As abstract published by PubMed.gov in 2002 provides this information: “Metallosis is usually defined as aseptic fibrosis, local necrosis, or loosening of a device secondary to metallic corrosion and release of wear debris. The abstract was a case study presented by Dipartimento di Scienze Radiologiche ed Ortopedico-Riabilitative Clinica Ortopedica e Traumatology, Università degli Studi di Siena, Siena, Italy and also says “We report the case of a patient who had severe metallosis caused by wear of the femoral head with the titanium socket, after the complete erosion and destruction of the polyethylene cup, with failure of the accetabular component. Breakage of the acetabular cup constitutes one of the possible long-term complications occurring as a result of a total hip replacement.”
The voluntary Stryker hip recall announced by the FDA on July 6, 2012 includes the following comments and recommendations “Stryker Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend. “Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data,” said Simpson.”
Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.
Stryker Hip Recall Defective Product Claims
Unfortunately, the announcement states the decision was a result of post-market surveillance but does not explain what specific adverse events, if any, were noted in post-market surveillance reports. Stryker Hip recall lawyers that have initiated Stryker Hip recall lawsuits are making defective product claims and alleging a number of Stryker Hip side effects including pain, partial or complete loss of mobility and additional surgeries.
Patients experiencing any of the above mentioned symptoms (pain, swelling, noise, sensation of movement or slipping of the implant, gait changes, loss of mobility) should seek medical attention. Individuals are also encouraged to obtain information about what type of implant they received. Some surgeons will provide the information at the time of surgery but if no, it should be available in medical/surgical records. It may be advisable to speak with a Stryker hip recall lawyer to discuss potential options, time limitations and all legal rights you may have.