A class re-call has been issued for the DePuy Synthes complete RCS knee system due to “higher rates of revision in Australia when the patella is not re-surfaced when compared to other un re-surfaced PS implants according to the U.S Food and Drug Administration (FDA Website). This is a class 2 re-call which means that the device may lead to temporary or medically reversible adverse events.
In March 2015 DePuy Synthes issued a field safety notice indicating “the potential occurance of pain when the native patella is not re-surfaced”. “When using the LCS component complete RPS knee system, the patella must be re-surfaced. Failure to resurface the patella has been associated with a higher incidence of post-operative patello-femoral pain potentially to a secondary procedure”. The notice read “the higher revision rates were flagged by regulators in Australia as the Australian joint replacement registry showed a 3.6 revision rate in one year for the LCS complete RPS compared to 0.3% with patella re-surfacing.
Any person In Ireland who may have received this device and suffered pain and complications as a result may be entitled to compensation. If you have been affected please contact our Firm today for expert advice.