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Medical Device Alert: Unicondylar sled knee prosthesis manufactured by Waldemar Link GmbH & Co. KG (MDA/2014/018)

Risk of early wear of the ultra high molecular weight polyethylene (UHMWPE) plastic part of the tibial plateau of this device.

 

In August 2013 Waldemar Link issued a Field Safety Notice informing clinicians that they had received reports of wear of the plastic part of the metal-backed tibial plateau Endo-Model® 7mm.

The manufacturer has informed the MHRA that the affected products have now been discontinued.

A total of 9 cases of wear of the plastic part of the device were reported to the manufacturer from outside of the UK. The implant failures occurred between 6 months and 5 years after implantation and analysis of the returned explants showed significant plastic wear. A definitive root cause for the wear events has not been determined by the manufacturer.

Wear of the plastic part of the plateau could lead to pain and stiffness. The debris generated by the wear could cause osteolysis, requiring device revision. In instances where wear leads to metal-on-metal contact, the resulting wear debris may lead to soft tissue damage requiring device revision.

442 devices were distributed in the UK between 2003 and 2013.

The MHRA is issuing this Medical Device Alert to ensure that clinicians are aware of this issue and consider appropriate follow up of patients implanted with affected devices.

Complete Notice HERE

 

 

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