HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY

Additional Manufacturer Narrative

NEITHER THE DURATION OF THE HEMICAP IMPLANT IN THE PATIENT NOR THE REASONS BEHIND INADEQUATE PAIN RELIEF ARE UNKNOWN. THE REP CONTACTED REVISION SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT, BUT THE SURGEON NEVER RESPONDED. THE EXACT CAUSE FOR REPORTED PAIN IS UNKNOWN. THE PART AND LOT INFORMATION OF THE DEVICE IN QUESTION ARE UNKNOWN. HENCE, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) CANNOT BE CONDUCTED. THE PACKAGE INSERT (PI) OF THE DEVICE STATES THAT THIS TYPE OF EVENT CAN OCCUR AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. AN APPROPRIATE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENTS WAS NOT PROVIDED. THE PATIENT HAS BEEN REVISED TO A FUSION AND HEMICAP DEVICE HAS BEEN EXPLANTED. SHOULD ARTHROSURFACE RECEIVE ANY ADDITIONAL INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT A HEMICAP PATIENT WAS REVISED DUE TO PAIN.