E1 RINGLOC ACETABULAR LINER 36MM SIZE 23 +3 HI-WALL

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 1 STATES "MATERIAL SENSITIVITY REACTIONS." 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." NUMBER 14 STATES "POSTOPERATIVE BONE FRACTURE AND PAIN."

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE APPROXIMATELY 3 YEARS POST-IMPLANTATION DUE TO PAIN AND POST-TRAUMATIC IMPLANT BREAKAGE. DUE TO THE LINER FRACTURE, THE CUP AND HEAD WERE ABLE TO ARTICULATE. GREY TISSUE, METAL EROSION, AND CORROSION ON THE TRUNNION WERE NOTED. THE CUP, LINER, AND HEAD WERE REMOVED AND REPLACED.