PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME

Additional Manufacturer Narrative

MPO WAS MADE AWARE OF REVISIONS WITH A STATED INDICATION OF INFECTION FROM A GERMAN REGISTRY REPORT (EPRD). SPECIFIC INFORMATION FOR EACH EVENT IS NOT AVAILABLE. INFECTION IS A KNOWN RISK OF ANY SURGICAL PROCEDURE. TRENDING DOES NOT REVEAL AN INCREASE IN RISK LEVEL FOR THIS PART FAMILY. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO PERFORM ANY FURTHER INVESTIGATION.

Description of Event or Problem

ALLEGEDLY, EPRD REPORTED 2 NEW COMPLICATIONS FOR PROFEMUR NECK COCR (2 INFECTION EVENTS). REVISION SURGERY. NO FURTHER INFORMATION WAS REPORTED. THIS INCIDENT IS CAPTURING 2 INFECTION EVENTS.