TRINITY

Additional Manufacturer Narrative

PER (B)(4). HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. HOWEVER THIS INFORMATION COULD NOT BE PROVIDED AND THUS THE SCOPE OF THIS INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. IN THE INITIAL REPORT, IT IS STATED THAT THE SURGEON WAS UNSURE OF THE MECHANISM OF INJURY AS THE PATIENT HAD NOT HAD A FALL HOWEVER THEY HAD BEEN LIFTED IN A LIFTING SWING ON THE WARD. IT HAS BEEN CONCLUDED THAT THE FRACTURE OF THE ACETABULUM CAUSED THE DISPLACEMENT OF THE CUP. THEREFORE THERE HAS BEEN NO MALFUNCTION OR DETERIORATION IN THE EFFECTIVENESS OF THE CORIN DEVICE. THE EXACT CAUSE OF THE FRACTURE IS UNKNOWN, HOWEVER COULD BE LINKED TO THE USE OF THE LIFTING SWING. THE ROOT CAUSE OF THE REPORTED FRACTURE IS EXTERNAL AS IT CANNOT BE LINKED TO DEVICE RELATED FACTORS PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

TRINITY REVISION OF THE CUP, ECIMA LINER, 2 SCREWS AND BIOLOX DELTA CERAMIC HEAD AFTER 1 WEEK DUE TO A FRACTURE IN THE ACETABULUM AND A DISPLACED CUP.

Additional Manufacturer Narrative

PER (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING: - A POST PRIMARY X-RAY? - OPERATIVE NOTES (PRIMARY AND REVISION). - PATIENT ACTIVITY LEVEL, WEIGHT AND MEDICAL HISTORY. - DID THE PATIENT FOLLOW THE CORRECT POST-OP PROTOCOL? - DID THE PATIENT EXPERIENCE ANY SLIPS / FALLS OR OTHER TRAUMA POST PRIMARY SURGERY? - WERE THERE ANY FIXATION CONCERNS DURING THE PRIMARY SURGERY? - AN UPDATE ON THE PATIENT POST REVISION. HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

TRINITY REVISION OF THE CUP, ECIMA LINER, 2 SCREWS AND BIOLOX DELTA CERAMIC HEAD AFTER 1 WEEK DUE TO A FRACTURE IN THE ACETABULUM AND A DISPLACED CUP.