E-POLY 32MM +3 HIWALL LNR SZ22

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. DATE OF EVENT - (B)(6) 2016. DATE IMPLANTED - (B)(6) 2015. DATE EXPLANTED - (B)(6) 2016. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." 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." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00685 & 1825034-2016-03152 / 03153). DEVICE REQUESTED, NOT YET RECEIVED.

Description of Event or Problem

PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY TEN MONTHS POST-IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, THE ACETABULAR LINER WAS NOTED TO BE FRACTURED. THE FEMORAL HEAD, ACETABULAR LINER AND CUP WERE REMOVED AND REPLACED.

Additional Manufacturer Narrative

THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNIV RNGLC SHL 48 MM/L22 P/N 11-103548 L/N 606460, CER BIOLOXD OPTION HD 32 MM P/N 650-1056 L/N 907600, CER OPTION TYPE 1 TPR SLEVE +3 P/N 650-1067 L/N 816140. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. COMPLAINT IS CONFIRMED WITH THE VISUAL INSPECTION. FRACTURED PIECE OF THE LINER EXHIBITS SCRATCHES AND DAMAGE. PRODUCT LIKELY MANUFACTURED TO THE SPECIFICATIONS AS THERE ARE NO DEVIATIONS FROM THE DEVICE HISTORY RECORDS THAT RELATES TO THE EVENT. THE APPEARANCE OF DISCOLORATION ON THE OUTER DIAMETER OF THE FEMORAL HEAD SUGGESTS THAT HEAD LIKELY CONTACTED THE ACETABULAR COMPONENT. PICTURES WERE REVIEWED WITH HEALTH CARE PROFESSIONAL AND DEVELOPMENT ENGINEER AND CONFIRMED THAT CUP POSITION WAS RETROVERTED. DEFORMATION WAS FOUND NEAR THE FRACTURED PART INDICATING THE HIGH WALL LINER WAS SUBJECTED TO OVER LOADING. IT IS POSSIBLE THAT THE IMPLANT POSITION LED TO IMPINGEMENT AND CAUSING EXCESSIVE WEAR AND LOADING ON THE HIGH WALL LINER RESULTING IN THE FRACTURE AND DISLOCATION OF THE HEAD. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.