UNKNOWN DEPUY LCS CRUCIFORM PRESSFIT PATELLA

Additional Manufacturer Narrative

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Additional Manufacturer Narrative

EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED UNANTICIPATED WEAR SECONDARY TO THE FRACTURED FEMORAL COMPONENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

Description of Event or Problem

PATIENT WAS REVISED TO ADDRESS A BROKEN, LOOSE FEMORAL COMPONENT, OSTEOLYSIS, AND POLY WEAR.