RINGLOC HIP SYSTEM ACETABULAR LINER

Additional Manufacturer Narrative

(B)(4). UDI- (B)(4). CONCOMITANT MEDICAL PRODUCT - RNGLC+ LTD HOLE SHELL SZ50 PN: 16-116050 LN:314590. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2017-09603.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO DISASSOCIATION OF THE LINER FROM THE ACETABULAR SHELL. THE LINER, LOCKING RING, AND HEAD WERE REVISED.

Additional Manufacturer Narrative

E-POLY +3 HI WALL LINER, RINGLOC LOCKING RING, A BIOLOX CERAMIC HEAD, AND A TAPER SLEEVE WERE RETURNED. THE RING AND LINER WERE ONLY EVALUATED AGAINST THE COMPLAINT. THE LOCKING RING IS BENT AND DEFORMED AT THE OPENING. DIMENSIONAL MEASUREMENTS OF THE LOCKING RING AS MEASURED WERE CONFORMING TO THE DEVICE PRINT SPECIFICATIONS. VISUAL EXAMINATION OF THE POLY LINER SHOWS THE SCALLOPS HAVE BEEN SHEARED OFF AND OUTER DIAMETER OF THE LINER EXHIBITS SCRATCHES AND GOUGES.THE LINER LOCKING RING GROOVE SHOWS LITTLE DAMAGE. CAUSE OF THE DAMAGE IS UNKNOWN. DIMENSIONAL ANALYSIS COULD NOT BE PERFOMED ON THE LINER DUE TO THE DAMAGE ON THE RETURNED DEVICE. ABRASIONS AND SCRATCHES ARE SEEN ON THE OUTER DIAMETER OF THE FEMORAL HEAD. THE DAMAGE LIKELY OCCURRED DURING REMOVAL OR DUE TO HEAD ARTICULATED AGAINST THE ACETABULAR SHELL. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. WITHOUT PHYSICAL EXAMINATION OF THE ACETABULAR SHELL AND REVIEW OF X -RAYS, THE REPORTED EVENT CANNOT BE CONFIRMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.