Class II Recall for DePuy LCS Complete RPS Knee SystemJun 5, 2015
On May 26, DePuy Orthopaedics issued a recall for the LCS Complete RPS Knee System after Australia's Therapeutic Goods Administration reported higher rates of revision (corrective surgery) when the native patella is not resurfaced during the original procedure.
If the LCS Complete RPS Knee System is implanted and the native patella (i.e., the patient's knee) is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
The Food and Drug Administration (FDA) has classified this as a Class II recall, its intermediate recall level. This is the recall designation for situations where use of the product may cause "temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
DePuy said data from the Australian Orthopaedic Association's National Joint Replacement Registry showed that the revision rate at one year for the LCS Complete RPS was 3.6 percent when the patella was not resurfaced, compared with 0.3 percent with patella resurfacing. The revision rate for the DePuy device spiked to 12.9 percent at four years with no resurfacing, compared with 3.3 percent with patellar resurfacing, MassDevice reports.
The recall includes 19,059 devices, all lots, various sizes, and both orientations. A list of catalog numbers can be found in the FDA recall notice. The devices were distributed through the US and worldwide in Canada, Australia, Austria, Belgium, UK, France, Greece, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, South Africa, Switzerland, and Thailand.
Notifications were sent to the affected distributors and medical professionals. All distributors were notified via email, and all medical professionals with affected inventory were also notified by distributor or sales consultant via in-person delivery or mail or by email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions about the recall, contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).
MassDevice reports that DePuy is revising the literature for the device to include the requirement to resurface the patella.