Probe into hip replacement parts

MEDICAL device maker Stryker has launched an investigation into a potential manufacturing issue with a product made at its Cork facility following concerns from the American Food and Drug Administration (FDA).

This announcement comes a day after the FDA ordered Stryker to fix a host of problems in its manufacturing of hip replacement parts at its New Jersey plant following multiple patient complaints. The investigation concerns a product known as Trident Acetabular Cups, a replacement hip product.

The investigation follows a warning letter sent by the FDA to the Cork plant following a site investigation.

The FDA is the American body that is responsible for the safety regulation of most types of foods, drugs and medical products.

It is understood that the Stryker investigation, which was launched before Christmas, does not concern the product itself but more the procedure used when washing or degreasing the product.

The Cork operation has been manufacturing the product for the past six years and it is also understood that the investigation could lead to a product recall.

Stryker spokesman, Aaron Kwittken, confirmed to the Irish Examiner yesterday that the company is investigating a “potential deviation from our internal manufacturing specifications of our Trident Acetabular Cups manufactured in our Cork facility”. He added there was “no evidence at this time to indicate that patient safety or efficacy of the product is an issue”.

Stryker employs close to 400 people between its plants in Cork and Limerick.

Earlier this week it was revealed that it received another warning letter from the FDA saying it failed to properly identify and correct recurring problems with some of its hip implants made at its Mahwah, New Jersey, facility.

Mr Kwittken said the Trident Acetabular Cups manufactured in Mahwah are not part of the internal investigation in Cork.

The warning letter from the FDA to Stryker regarding its Mahwah plant discussed patient complaints received about problems such as improper fitting of hip plants that caused bone fractures, complaints about pain, difficulty walking and parts breaking off or wearing down unevenly.

The letter was prepared after FDA officials spent weeks inspecting the company’s orthopedics division headquarters in Mahwah.