Johnson & Johnson‘s (NYSE:JNJ) DePuy Synthes joint reconstruction division warned surgeons on the technique used to implant its LCS Complete RPS knee replacements, after Australian regulators flagged a spike in revision rates.
DePuy issued a field safety notice in March warning "due to the potential occurrence of pain when the native patella is not resurfaced."
"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," according to the safety notice.
DePuy said Australia’s Therapeutic Goods Administration told it that data from the Australian Orthopaedic Assn.’s National Joint Replacement Registry showed that the revision rate at 1 year for the LCS Complete RPS was 3.6% when the patella was not resurfaced, compared with 0.3% with patella resurfacing. The revision rate for the DePuy device spiked to 12.9% at 4 years with no resurfacing, compared with 3.3% with patellar resurfacing, DePuy said.
Since 2006, 15,571 LCS Complete RPS femoral implants and 17,732 LCS Complete RPS inserts were sold in the U.S., DePuy said. Outside the U.S., 3,263 femoral implants and 3,546 inserts for the LCS Complete RPS were sold.
DePuy said it’s revising the literature for the device to "include verbiage around the requirement to resurface the patella."
The FDA gave the warning Class II recall status, denoting "a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."