E-POLY 32MM +3 MAXROM LNR SZ22

Additional Manufacturer Narrative

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - UNKNOWN; DEVICE CODE - UNKNOWN; EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - 2012; DATE EXPLANTED - REMAINS IMPLANTED; INITIAL REPORTER - UNKNOWN; PMA/510(K) NUMBER / MANUFACTURE DATE ¿ UNKNOWN. REMAINS IMPLANTED.

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE IN 2012. SUBSEQUENTLY, THE SURGEON NOTED OSTEOLYSIS ON FILMS DURING A FOLLOW UP ON AN UNKNOWN DATE IN 2016. THERE HAS BEEN NO REPORTED REVISION TO DATE.

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 WERE NOTED. ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO IMPINGEMENT OF THE LINER. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00745 / 01397 / 02592).

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-00745 / 01397).

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN SIDE ON (B)(6), 2012. SUBSEQUENTLY, THE SURGEON NOTED OSTEOLYSIS ON FILMS DURING A FOLLOW UP ON (B)(6), 2016. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS REVISED ON (B)(6), 2016 DUE TO WEAR AND PAIN. THE HEAD, SHELL, LINER AND LOCKING RING WERE REMOVED AND REPLACED.