OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM, CANNULATED 4.0X70MM

Description of Event or Problem

REVISION SURGERY DUE TO PAIN AND SWELLING FOLLOWING IMPLANTATION IN THE PROXIMAL TIBIA. A PROUD OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL 4.0X70 MM WAS TRIMMED DOWN.

Additional Manufacturer Narrative

COMPANY WAS INFORMED OF AN IMPLANT REVISION SURGERY THAT WAS PERFORMED FOLLOWING AN IMPLANTATION PROCEDURE IN THE PROXIMAL TIBIA. NO IMMEDIATE POST-OP IMAGING WAS PROVIDED. AN MRI IMAGING WAS REPORTED TO HAVE IDENTIFIED A PROUD IMPLANT ON THE MEDIAL SIDE OF THE KNEE. SWELLING AND PAIN WAS ATTRIBUTED TO INCORRECT POSITIONING OF THE IMPLANT. THE PROUD IMPLANT WAS TRIMMED DOWN IN A REVISION SURGERY AT AN UNKNOWN DATE. BASED ON THE INVESTIGATION OF ALL AVAILABLE DATA, IT IS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN IMPROPER SURGICAL PROCEDURE WHICH RESULTED IN AN INCORRECT POSITIONING OF THE IMPLANT I.E. PROUD MEDIALLY. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, AND SURGICAL SITE PREPARATION. AS A REVISION SURGERY WAS PERFORMED AND BECAUSE THE COMPANY CANNOT RULE OUT THE POSSIBLE CONTRIBUTION OF THE DEVICE TO THE EVENT, OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE INITIAL IMPORTER RELATING TO THIS EVENT IS.