TRINITY

Description of Event or Problem

TRINITY REVISION OF THE CUP, ECIMA LINER, MODULAR HEAD AND 2 SCREWS FOLLOWING A FALL WHICH HAS MADE THE PRIMARY HIP UNSTABLE.

Additional Manufacturer Narrative

PER COMP (B)(4). INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING: OPERATIVE NOTES (PRIMARY AND REVISION) PATIENT AGE, ACTIVITY LEVEL, WEIGHT AND MEDICAL HISTORY. WHAT THE PATIENT WAS DOING AT THE TIME OF THE FALL . WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL . 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 OCCURRED 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 CONTRIBUED TO THIS EVENT.

Additional Manufacturer Narrative

PER (B)(4) FINAL REPORT ADDITIONAL INFORMATION, INCLUDING: - OPERATIVE NOTES (PRIMARY AND REVISION). - PATIENT AGE, ACTIVITY LEVEL, WEIGHT AND MEDICAL HISTORY. - WHAT THE PATIENT WAS DOING AT THE TIME OF THE FALL. - WHETHER THE PATIENT FOLLOWED CORRECT POST-OP PROTOCOL. - AN UPDATE ON THE PATIENT POST REVISION. HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT HOWEVER, NONE OF THESE DETAILS WERE PROVIDED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. AS THE INSTABILITY AND SUBSEQUENT REVISION WERE DUE TO THE PATIENT EXPERIENCING A FALL AND NOT LINKED TO THE DEVICE DESIGN OR PERFORMANCE, NO FURTHER INVESTIGATION IS REQUIRED AND THUS THIS CASE IS NOW 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 OCCURRED 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, MODULAR HEAD AND 2 SCREWS FOLLOWING A FALL WHICH HAS MADE THE PRIMARY HIP UNSTABLE.