Medical Device Manufacturer Recalls Hip Replacement Part
A Tennessee-based medical device company has issued a recall for a prosthetic part used in hip joint replacement surgeries. According to one news source, the recall is a Class I recall. Class I recalls are issued when there is a reasonable probability that continued use of the device will cause serious health problems or even death.
The part is one of three prosthetic parts used in a total hip replacement surgery. According to the U.S. Food and Drug Administration, the part has been fracturing more than anticipated after surgical implantation. If a fracture occurs, patients may suffer from an array of symptoms, including pain, instability, and trouble walking. Fractures may also require emergency surgery to replace and repair the broken part. This is called revision surgery, which is often more complex and risky than original hip replacement surgery.
As a result of the recall, the company has informed product distributors, hospital personnel, and surgeons to cease selling and using the recalled part. The company has also recommended that patients immediately contact their doctor if they experience sudden pain, instability, difficulty walking, tingling, or a loss of feeling in the surgical leg. For patients not experiencing any of these symptoms, the company does not recommend following up with a medical professional at this time.
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