FEMORAL HEAD BIOLOX DELTA CERAMIC

Description of Event or Problem

ALLEGEDLY, EPRD REPORTED 5 NEW COMPLICATIONS FOR BIOLOX CERAMIC HEAD (5 DISLOCATION /INSTABILITY EVENTS). REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED. THIS INCIDENT IS CAPTURING 5 DISLOCATION /INSTABILITY EVENTS.

Additional Manufacturer Narrative

MPO WAS MADE AWARE OF REVISIONS DUE TO DISLOCATION FROM A GERMAN REGISTRY REPORT (EPRD). SPECIFIC INFORMATION FOR EACH EVENT IS NOT AVAILABLE. DISLOCATION AND INSTABILITY ARE KNOWN RISKS OF TOTAL HIP ARTHROPLASTY. TRENDING DOES NOT REVEAL AN INCREASE IN RISK LEVEL FOR THIS PART FAMILY. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO PERFORM ANY FURTHER INVESTIGATION.