DePuy Issues Safety Notice for LCS Knee System

DePuy Orthopaedics, Inc. issued a voluntary Field Safety Notice (FSN) for all lots of its LCS Complete RPS Knee System (LCS) this past March.

Higher Revision Rates

Australia’s regulatory body, the Therapeutic Goods Administration (TGA), had recently notified the company that based on information from the Australian Orthopaedic Association National Joint Replacement Registry; the system has a higher rate of revision when the native patella is not resurfaced than other unresurfaced knee systems. In fact, almost four times the rate. At four years, the LCS had a 12.9% revision rate versus 3.6% of other systems, when the patella was not resurfaced.

According to data from the registry, failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain, potentially leading to a secondary procedure. As a result, the company is warning against use of the LCS system without resurfacing the native patella.

The units affected since 2006, according to the Notice, include, “15, 571 LCS COMPLETE RPS Femoral Implants and 17, 732 LCS COMPLETE RPS Inserts sold in the U.S. and 3, 263 LCS COMPLETE RPS Femoral Implants and 3, 546 LCS COMPLETE RPS Inserts sold outside of the U.S.”

This device correction does not affect any other LCS complete knee femoral implants or inserts.

Intended Use

The LCS system is intended for total knee replacement and consists of a femoral implant and the compatible LCS insert. The LCS 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.

Corrective Action

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

1. Advise users to resurface the patella with any of the LCS knee patella implants when implanting the affected implants.
2. Revise product literature to include verbiage around the requirement to resurface the patella with any of the LCS implants when implanting the affected implants.
3. Remind users that product complaints should be reported through the normal complaint reporting process.

Clinical Implications

If the system is implanted and the native patella is not resurfaced, the company says the patient may experience patello-femoral pain, potentially requiring a secondary procedure. Following are examples of possible risks/hazards of secondary procedures:

1. Infection
2. Additional scarring
3. Neural and vascular damage
4. Additional pain to the patient
5. Functional problems resulting from items 1 – 4 above
6. Anesthesia-associated risks

DePuy is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the system with an unresurfaced patella.