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Field Safety Notice Issued By Biomet UK Ltd Over Hip Replacement Components

A Manufacturing Error Led To The Fault With The Component


A field safety corrective action has been initiated by Biomet UK Ltd concerning its M-H 6 Hole Shell HA/PC implant used in hip replacements.

The company has requested that hospitals using the component in operations locate and discontinue the use of the implant.

There are concerns that lot 3072321 of the Mallory Head HA/PC acetabular shell were manufactured without an HA coating, which is designed to enhance bone growth into the porous layer of the acetabular implant.

Biomet UK Ltd has urged hospitals using the component in total hip replacement procedures to make all staff aware of the issue, which was identified following a complaint, and to withdraw the affected implants from use.

The company noted that those unfamiliar with the HA Coated Mallory-Head Shell would not easily notice that the implant has been manufactured without the required coating.

Expert Opinion
Patients undergoing any type of invasive procedure, such as a total hip replacement, must receive the best quality care, which means receiving the best possible medical devices during their procedure.

“It is vital Biomet UK Ltd thoroughly investigates the failings that resulted in these components being distributed to medical facilities and used during operations.

“This is another case where concerns have been raised regarding a medical product and it is important regulators also take action to explain to clinicians and patients how this problem occurred, as well as what is being done to prevent recurrence in the future.”
Kevin Timms, Solicitor

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