The TGA has issued a hazard alert for a component used in knee replacements.

Surfaces of the Genesis II Knee System non-porous tibial baseplates do not meet the product’s specifications, and parts of the affected devices have inadequate surface roughness, the alert said.

“This could result in poor fixation and loosening of the baseplate, which may lead to the device failing and the need for revision surgery,” it said.

However manufacturer Smith & Nephew Surgical say the health risks for patients who have an affected device is low.

Orthopaedic surgeons who have implanted the affected devices have been notified and to date there have been no reports of associated adverse events in Australia or overseas, the TGA said.

The affected model number is 71420182 with batch number 14CT39993.