Warning relating to DePuy total knee implant
DePuy Orthopaedics, Inc. has voluntarily issued an urgent Field Safety Notice(FSN) regarding its LCS COMPLETE RPS Knee System. The FSN is being issued due to the potential occurrence of pain when the native patella is not resurfaced.
This matter came to light following a notification by the Australian regulatory authority, the Therapeutic Goods Administration (TGA) that the LCS COMPLETE RPS Knee System has a higher rate of failure than the class of PS knee systems. This is based on data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJPR). After further analysis of this data, DePuy has determined that the LCS COMPLETE RPS Knee System has a higher rate of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. This results in post-operative petello-femoral pain and therefore the potential need for further surgery to resurface the native patella.
Data provided by the AOANJPR indicates the cumulative revision rate at 4 years to be 12.9% compared to 3.6% with other unresurfaced PS implants. Therefore, DePuy is warning against use of the LCS COMPLETE RPS Knee System without resurfacing of the native patella.
The LCS COMPLETE RPS Knee System is intended for use in total knee replacements in the cases of osteoarthritis and rheumatoid arthritis. It consists of an LCS COMPLETE RPS Femoral Implant and the compatible LCS COMPLETE RPS Insert. Since 2006, 15,571 LCS COMPLETE RPS Femoral Implants and 17,832 LSC COMPLETE RPS Inserts were sold in the U.S. and 3,263 LCS COMPLETE RPS Femoral Implants and 3,546 LSC COMPLETE RPS Inserts were sold outside the U.S.
DePuy recommends that patients with pain discuss symptoms with their surgeon and the clinical implications of such symptoms along with the risks associated with a second procedure including:
- Additional scarring
- Neural and vascular damage
- Additional pain to the patient
- Functional problems relating from items 1-4 above
- Anaesthesia associated risks.
This is not the first time knee replacements have been the focus of scrutiny. In 2010, the LCS Duofix implant, also manufactured by DePuy was recalled as a result of increased revision rates.
"Patients have every right to expect medical devices are vigorously tested before being used and it is imperative for manufacturers to act quickly to recall products and issue alerts when problems come to light."
Leigh Day specialises in pursuing claims for individuals implanted with substandard medical devices which have failed prematurely which, amongst others, include pursuing claims for over 1000 clients who have failed metal on metal hip components .