You May Have the Right to Sue for Compensation
DePuy Orthopaedics, a company owned by Johnson & Johnson, issued an “Urgent Field Safety Notice” to medical providers regarding the LCS COMPLETE RPS Knee System, which is used in orthopedic knee joint replacement surgery on patients with osteoarthritis and rheumatoid arthritis. Models names of products used with the the LCS Complete Knee System include:
- LCS Complete RPS Femoral Implant
- LCS Complete RPS Insert.
The field notice is not a recall of these products. It notifies healthcare providers of the possible need for revision surgery to implant a surface on the patella (kneecap).
The field safety notice involves all lots of the LCS Complete RPS Knee System. It was issued because of the potential occurrence of pain when the natural patella is not resurfaced, according to the field safety notice, and the remedy is revision surgery, which has possible risks and hazards, including but not limited to, the following:
- Infection;
- Additional scarring;
- Neural and vascular damage;
- Additional pain;
- Functional problems resulting from items 1 – 4 above; and
- Anesthesia-associated risks.
Knee Pain Leads to Revision Surgery
The Therapeutic Goods Administration in Australia informed DePuy that the LCS Complete RPS Knee System has a higher rate of revision than certain other knee systems. This was based on recent data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR):
An analysis of 350 resurfaced and 305 unresurfaced LCS Complete RPS Knee Replacements in Australia found that, after 4 years, there was a 3.3% revision rate when the patella was resurfaced and a 12.9% revision rate when the patella was not resurfaced.
DePuy analyzed this data and issued this field safety notice, informing healthcare providers that, when using the LCS Complese RPS Knee System, the patella must be resurfaced. DePuy took this action even though, according to DePuy, the global complaint rate is not as high as in Australia:
- LCS Complete RPS Femoral Implants global complaint rate is 0.51%.
- LCS Complete RPS Inserts global complaint rate is 0.75%.
Since 2006, 15,571 LCS COMPLETE RPS Femoral Implants and 17,732 LCS COMPLETE RPS Inserts were sold in the U.S. This device correction does not affect any other LCS COMPLETE Knee femoral implants or inserts.