Thursday, June 11, 2015

News: Class 2 Device Recall DePuy Orthopaedics LCS - COMPLETE RPS

Urgent Field Safety Notice (FSN)
Product Name: DePuy - LCS COMPLETE RPS Knee System
FSCA-identifier: 103108200-HHE
Type of Action: Field Safety Notice
Date: March 2015

Attention: Trust Chief Executives, the Clinical Director-Orthopaedic Department, the Orthopaedic Theatre Manager, the Safety Liaison Officer, General Managers – Private Sector Hospitals

Type of device: Devices used in Orthopaedic Knee Joint Replacement.

Model names: LCS COMPLETE RPS Femoral and the LCS COMPLETE RPS Insert.

DePuy Orthopaedics, Inc. is voluntarily issuing a Field Safety Notice (FSN) for all lots of the LCS® COMPLETE™ RPS Knee System (See Attachment A). The FSN is being issued due to the potential occurrence of pain when the native patella is not resurfaced, as reported in the Australian Registry. When using the LCS Complete RPS Knee System, the patella must be resurfaced. Failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain potentially leading to a secondary procedure.

DePuy Orthopaedics, Inc. was recently notified by Australia’s regulatory authority, the Therapeutic Goods Administration (TGA), that the LCS® COMPLETE™ RPS Knee System has a higher rate of revision than the class of PS knee systems based on recent data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). After further analysis of the AOANJRR data, DePuy Orthopaedics, Inc. determined that the LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. The need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain.

...... Published at MHRA Regulating Medicines and Medical Devices. You may download the document after clicking MHRA link above or FDA link.

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