ZIMMER TRABECULAR METAL REVERSE VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER

Additional Manufacturer Narrative

(B)(4). CONCOMITANT DEVICES - COMPREHENSIVE REVERSE BASEPLATE CATALOG #: 010000589 LOT #: 392840, COMPREHENSIVE REVERSE GLENOSPHERE CATALOG #: 115310 LOT #: 001270, COMPREHENSIVE REVERSE CENTRAL SCREW 6.5 MM X 25 MM CATALOG #: 115381 LOT #: 073930, COMPREHENSIVE LOCKING SCREW 3.5 MM X 4.75 MM CATALOG #: 180550 LOT #: 151500, COMPREHENSIVE LOCKING SCREW 3.5 MM X 4.75 MM CATALOG #: 180554 LOT #: 278260, COMPREHENSIVE LOCKING SCREW 3.5 MM X 4.75 MM CATALOG #: 180557 LOT #: 207320, COMPREHENSIVE LOCKING SCREW 3.5 MM X 4.75 MM CATALOG #: 180558 LOT #: 639360, TRABECULAR METAL REVERSE HUMERAL STEM CATALOG #: 00434901213 LOT #: 63685104, TRABECULAR METAL REVERSE VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE LINER CATALOG #: 00435003600 LOT #: 63113805. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT IS REPORTED THAT DURING REVERSE SHOULDER ARTHROPLASTY, THE SURGEON HAD DIFFICULTY ASSEMBLING THE POLYETHYLENE LINER WITH THE HUMERAL STEM. AN ALTERNATIVE LINER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. LINER WAS RETURNED FOR EVALUATION. DIMENSIONS TAKEN ARE WITHIN SPECIFICATIONS. THE DEVICE EXHIBITS WITNESS MARKS AT THE SLOT THAT ACCEPTS THE ANTI-ROTATION BOSS OF THE STEM. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. THE TM REVERSE SURGICAL TECHNIQUE STATES ON PAGE 30: ¿ALSO MAKE SURE THAT THE GUIDE PIN ON THE POLY LINER IMPACTOR IS ALIGNED INTO THE POST ON THE LATERAL SIDE OF THE STEM FACE PRIOR TO IMPACTING¿. THE WITNESS MARKS AROUND THE SLOT THAT ACCEPTS THE ANTI-ROTATION BOSS OF THE STEM INDICATE THAT THE LINER WAS NOT SUITABLY ALIGNED WITH THE ANTI-ROTATION BOSS OF THE STEM AND THIS LIKELY CAUSED THE EVENT. ROOT CAUSE IS DETERMINED TO BE USER ERROR. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.