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Unicondylar Sled knee prosthesis subject of medical device alert

Knee replacement device under scrutiny from regulatory body

Alert issued on commonly used knee device

30 May 2014

The Medicines and Healthcare Products Regulatory Authority (MHRA) has recently issued a Medical Device Alert identifying a potential defect with a commonly used knee replacement which is distributed in the UK.

According to the MHRA, the LINK® Unicondylar Sled Knee Prosthesis, created by German manufacturer Waldemar Link GmbH & Co, carries a risk of early failure.

A plastic part contained in the knee replacement device releases ‘ultra high molecular weight polyethylene’ (UHMWPE) particles into the knee and the soft tissue that surrounds the knee. 

‘Significant plastic wear’ was shown to have taken place when devices that had been returned to the manufacturer were analysed.

The affected component is the Metal-Backed Tibial Plateau Endo-Model® 7mm.

Polyethylene wear is widely considered to cause osteolysis of the joints, resulting in the destruction of bone tissue and symptoms of pain and stiffness in and around the knee.

It can lead to early loosening of the knee components, and even to bone fractures.

The MHRA has reported that, in severe cases, the plastic component of the Unicondylar Sled Knee Prosthesis has completely worn through.

This means the two metal components contained in the knee replacement can rub together, leading to the release of metal particles into the body.

The MHRA say that “the resulting wear debris may lead to soft tissue damage requiring revision”.

In August 2013, Waldemar Link released an ‘Urgent Notice on Safe Use of a Product’ and concerns arose that the release of UHMWPE wear particles from the knee implant would mean that patients fitted with the device would need revision surgery.

The manufacturer has now discontinued the product.

The MHRA alert has been distributed to all major health authorities in the UK and Northern Ireland, suggesting that reviews of patients implanted with the affected device should be carried out.

If you have suffered injuries or poor health as a result of an orthopaedic device being fitted you are welcome to speak to a member of our experienced medical devices team for a free consultation.

Please contact solicitors Jill Paterson or Tom Jervis on 020 7650 1219 for a free discussion, or fill in our enquiry form and someone will get back to you shortly

Information was correct at time of publishing. See terms and conditions for further details.

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