Earlier this month, Depuy Synthes issued the following Field Safety Notice regarding the implantation of a line of knee replacement products:

LCS COMPLETE RPS Knee System (Photo Provided)

DePuy Orthopaedics, Inc. is voluntarily issuing a Field Safety Notice (FSN) for all lots of the LCS® COMPLETE™ RPS Knee System. 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.

The LCS COMPLETE RPS Knee System is intended for total knee replacement and consists of an LCS COMPLETE RPS Femoral implant and the compatible LCS COMPLETE RPS Insert. The LCS COMPLETE RPS Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RPS inserts and femoral implants are indicated where a higher than normal degree of post operative flexion is required.

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 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.

Since 2006, 15,571 LCS COMPLETE RPS Femoral Implants and 17,732 LCS COMPLETE RPS Inserts were sold in the U.S. and 3,263 LCS COMPLETE RPS Femoral Implants and 3,546 LCS COMPLETE RPS Inserts were sold outside of the US. This device correction does not affect any other LCS COMPLETE Knee femoral implants or inserts.

The company is taking the following steps for this device correction:

• Advise users to resurface the patella with any of the LCS COMPLETE Knee patella implants when implanting the affected implants.
• Revise product literature to include verbiage around the requirement to resurface the patella with any of the LCS COMPLETE Knee patella implants when implanting the affected implants.
• Users are also reminded that product complaints should be reported through the normal complaint reporting process.

To see the full Field Safety Notice visit https://www.hpra.ie/docs/default-source/field-safety-notices/march-2015/v23613_fsn.pdf?sfvrsn=2