CONTINUUM ACETABULAR TM SHELL W/UNI-HOLE

Description of Event or Problem

IT IS REPORTED THAT AFTER THE SHELL WAS IMPACTED, THE SURGEON ATTEMPTED TO UNSCREW THE TRILOGY CUP IMPACTOR FROM THE SHELL. AFTER SEVERAL ATTEMPTS, THE CUP WOULD NOT DISENGAGE. THE CUP WAS REMOVED FROM THE PELVIS. THE ACETABULUM WAS REAMED UP TO A 63 AND A 64 CLUSTER HOLE CUP WAS INSERTED.

Additional Manufacturer Narrative

INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE LOT NUMBER OF THE INSERTER USED TO IMPACT THE SHELL IS UNK. THE CONDITION OF THE IMPACTOR BOLT AT THE TIME IT WAS THREADED INTO THE SHELL IS UNK. IT IS UNK WHETHER THE SURGICAL TECHNIQUE FOR THE CONTINUUM SHELL WAS FOLLOWED WHICH STATES "DO NOT LEVER ON THE SHELL OR THE CUP INSERTER TO REPOSITION THE IMPLANT, AS DAMAGE MAY OCCUR TO THE THREADS OR INNER DIAMETER OF THE SHELL". GIVEN THE INFORMATION PROVIDED AND THE ANALYSIS PERFORMED, A DEFINITIVE CAUSE FOR THE EXPERIENCE OF NOT BEING ABLE TO UNTHREAD THE INSERTER FORM THE SHELL CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION CODES: THE DEVICE HISTORY RECORD FOR THE SHELL WAS REVIEWED AND FOUND TO BE CONFORMING TO MANUFACTURING, INSPECTION, AND PACKAGING SPECIFICATIONS. THE RETURNED SHELL SHOWS CHATTER MARKS ON THE FLAT CREST OF THE POLAR HOLE THREADS. IN ADDITION THERE APPEARS TO BE MATERIAL AT THE EDGES OF THE THREAD FLATS THAT WAS DEFORMED.