Smith & Nephew blamed the error on a subcontractor that mislabeled thedevices, which caused a mismatch between the two hip implants. This meant that patients requiring a hip device of a different size received a mislabeled hip implant, which resulted in their hip implant failure.
The mismatched pieces result in loosely fitting implants. Patients that have undergone hip replacement surgery using Smith & Nephew Birmingham hip device are advised to consult their doctors and go for a post-operation X-ray to confirm whether they have properly fitting implants.
In case they are found to have the improperly fitting hip device, revision surgery is the only solution.
Recently, the Federal Drug Administration warned Smith & Nephew PLC about the quality control problems at one of the company’s plants in Germany, which manufactures hip replacement implants. The warning letter calls for corrective action at Smith & Nephew’s Tuttlingen, Germany, production unit, where R3 Ceramic Acetabular System is manufactured. Before issuing the warning, FDA inspection teams visited the plant in July 2010 and raised a few serious concerns, including failure of the company to confirm validity of the Germany plant’s maximum and minimum settings for equipment used to press titanium rings. The company’s response to the concerns was deemed insufficient by the FDA.
The inspection team also found that the Germany plant did not verify that corrective actions to fix a problem with radiation-sterilized plants were actually working. The FDA inspectors found that no procedure was in place at the plant facility to ensure that the fixes were working. However, the plant put the entire blame on its employees’ failure to follow the new procedure. The FDA inspection report found that the company’s processes to validate the quality of its products lacked in numerous areas.
The metal-on-metal Birmingham Hip Resurfacing System is surgically implanted to replace a hip joint damaged due to degenerative diseases, including rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia; improve hip function; and relieve hip pain.
However, this metal-on-metal hip device has proved troublesome for many patients, who have experienced metallosis and extreme pain due to deposition of fluid and debris around the hip joint as a result of the wearing off of the metal particles. In such a case, the hip cup impinges or rubs on surrounding muscle, which eventually causes the joint to wear off, resulting in metal ion poisoning and generating immense pain.
Many patients have experienced flu-like symptoms, including lethargy, headaches, aching joints, and a feeling of malaise. So far, more than 50,000 patients have received Birmingham Hip Resurfacing implants, and that the number of affected patients is on the rise.