E-POLY 32MM +3 HIWALL LNR SZ22

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION. WEAR AND DEFORMATION OF THE DEVICE WAS NOTED. A CONCLUSIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION DUE TO A FRACTURED POLY COMPONENT. DURING THE PROCEDURE, THE HEAD AND POLY COMPONENT WERE REMOVED AND REPLACED.

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, AND/OR EXCESSIVE WEIGHT.¿ PRODUCT LOCATION UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2016 DUE TO A FRACTURED POLY. IT WAS FURTHER REPORTED THAT A FIFTY (50) MINUTE DELAY IN PROCEDURE OCCURRED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW UP REPORT IS BEING FILED TO CORRECT INFORMATION.