TRINITY

Additional Manufacturer Narrative

PER 9694 - 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, AND WHETHER THE SURGEON HAD TO SWITCH TO A COMPETITOR PRODUCT, WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND WAS PROVIDED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED, AND THE RELEVANT DEVICE MANUFACTURING RECORDS OF THE INSTRUMENT AND OF THE IMPLANT HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS FAILURE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND AS A RESULT OF FEEDBACK, A DESIGN CHANGE HAS BEEN IMPLEMENTED TO THE TRINITY HANDLE. THE DEVICE RELATED TO THIS REPORT WAS MANUFACTURED PRIOR TO THE CHANGE AND THUS THIS CASE IS CONSIDERED CLOSED. 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 STD INTRODUCER / IMPACTOR HANDLE: COULD NOT BE REMOVED FROM THE IMPLANT.

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. 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 STD INTRODUCER / IMPACTOR HANDLE: COULD NOT BE REMOVED FROM THE IMPLANT.