Shannon based Zimmer Biomet has Hip Implant Device Recalled

The US Food and Drug Administration (FDA) has recalled the Zimmer Hip Implant because of a manufacturing mishap. Zimmer, now known as Zimmer Biomet, established a manufacturing facility in Shannon in 2007.
The FDA issued the Class 1 recall, the most serious level of recall, for the M/L Taper Hip Implant. This device is part of a modular system of femoral necks and stems able to be custom-fitted to a patient’s body.
The recall was because the company found a process monitoring failure that led to higher than expected amounts of manufacturing residue left on the devices.
The recall is also due to a risk of metallosis which is a problem often associated with metal-on-metal hip implants. The symptoms can include skin rash, heart disease, hearing or visual impairment, kidney failure if left untreated, depression, thyroid dysfunction, fatigue or neck discomfort.
Speaking about the latest recall of hip implant devices, Liam Moloney, a Product Liability Solicitor of Naas, Co. Kildare, said today “metal-on-metal implants can cause debilitating side effects such as pain, swelling, tissue damage or possible revision surgery”.
Mr Moloney continued “if any patient has received the M/L Taper Hip Implant they should immediately contact their implanting Surgeon, so that they can immediately undergo MRI scans to determine if the device is functioning correctly or not. They will also have to undergo blood tests to establish that they do not have elevated metal ion levels in their blood”.