TRINITY

Additional Manufacturer Narrative

(B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY CUP, WHETHER THE CUP WAS ALREADY IMPACTED WITHIN THE ACETABULUM AND THEN HAD TO BE EXPLANTED DUE TO THE ISSUE WITH THE HANDLE, DID THE SURGEON HAVE TO RE-REAM AND IMPLANT A LARGER SIZE OR WAS THE SAME SIZE CUP IMPLANTED AND WHETHER THE SURGEON HAD TO SWITCH TO A COMPETITOR PRODUCT, WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NONE OF THESE DETAILS WERE PROVIDED AND THUS THE SCOPE OF THIS INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS FOR THE HANDLE 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. THE APPROPRIATE DEVICE DETAILS FOR THE ASSOCIATED TRINITY SHELL WERE NOT PROVIDED AND THUS THESE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE REPORTED DEVICES HAVE NOT BEEN RETURNED FROM THE FIELD AND THUS CANNOT BE EXAMINED. THE REPORT CANNOT BE VERIFIED AND ROOT CAUSE NOT DETERMINED. BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THUS THIS CASE IS NOW CONSIDERED CLOSED. HOWEVER, SHOULD THE DEVICES BE RETURNED THEN THIS CASE CAN BE RE-OPENED FOR FURTHER INVESTIGATION. 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 STD INTRODUCER / IMPACTOR HANDLE: WOULD NOT COME OFF THE TRINITY CUP.

Additional Manufacturer Narrative

(B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY CUP, WHETHER THE CUP WAS ALREADY IMPACTED WITHIN THE ACETABULUM AND THEN HAD TO BE EXPLANTED DUE TO THE ISSUE WITH THE HANDLE, DID THE SURGEON HAVE TO RE-REAM AND IMPLANT A LARGER SIZE OR WAS THE SAME SIZE CUP IMPLANTED AND WHETHER THE SURGEON HAD TO SWITCH TO A COMPETITOR PRODUCT, 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. 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 STD INTRODUCER / IMPACTOR HANDLE: WOULD NOT COME OFF THE TRINITY CUP.