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DePuy Orthopaedics announces field safety notice for knee system

DePuy Orthopaedics recently voluntarily issued a field safety notice for its LCS Complete RPS Knee System due to the potential occurrence of pain when the native patella is not resurfaced.

DePuy was recently notified by Australia’s regulatory authority, the Therapeutic GoodsAdministration (TGA), that the LCS Complete RPS Knee System has a higher rate of revision than the class of PS knee systems based on data from The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Because there is an increased incidence of postoperative patellofemoral pain, there is a need for a second surgery to resurface the native patella, according to the safety notice.

The company is advising users to resurface the patella with any of the LCS Complete Knee patella implants when implanting the affected implants and will revise the product literature around this requirement. DePuy also reminded users that product complaints should be reported through the normal complaint-reporting process.

Since 2006, the LCS Complete Femoral Implants global complaint rate was 0.51% and the LCS Complete RPS inserts global complaint rate was 0.75%, according to data from the AOANJRR.

According to the safety notice, this device correction recommended by the company does not affect any other LCS Complete Knee femoral implants or inserts.

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