EXPLOR 7X26MM IMPL STEM W/SCR

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: POSTOPERATIVE LATERAL X-RAY ON SHOWED NORMAL POSITION/ALIGNMENT OF THE REVISED EXPLOR RADIAL HEAD MODULAR SYSTEM. SUBSEQUENT LATERAL X-RAY ON 6 MONTHS LATER SHOWED DISASSEMBLY OF THE MODULAR RADIAL HEAD SYSTEM. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ALL THREE ITEMS SHOW SIGNS OF USE AND WEAR AND TEAR. THE HEAD RETURNED HAS SCRATCHES ON THE BOTTOM OF THE HEAD AND THERE IS WEAR AND TEAR IN THE GROOVE OF THE HEAD WHERE THE STEM WOULD BE INSERTED. THERE IS ALSO WEAR AND TEAR ON THE WORKING SURFACE OF THE HEAD. THE HEAD DIAMETER AND ASSEMBLY/GROOVE SLOT WIDTH WERE MEASURED AND CONFORMING. THE STEM RETURNED HAS SCRATCHES AND GOUGING ON THE GROOVE OF THE STEM THAT WOULD BE INSERTED INTO THE HEAD. THERE ALSO APPEARS TO BE SOME DEBRIS ATTACHED TO THE BOTTOM SIDE OF THE STEM AND THE COATING AS WELL. THE STEM DIAMETER AND WIDTH OF THE GROOVE ASSEMBLY FEATURE WERE MEASURED AND CONFORMING. THE SCREW RETURNED HAS SOME DAMAGE TO THE THREADS. THE SHAFT DIAMETER AND OVERALL SCREW LENGTH WERE MEASURED AND CONFORMING. ALL THREE ITEMS WERE RETURNED DIS-ASSEMBLED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: MEDICAL PRODUCTS: ITEM#: 11-210033, EXPLOR 14X22MM IMPLANT HEAD; LOT#: 65978244. G2: FOREIGN: BELGIUM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AND FOUR MONTHS AGO. THE PATIENT UNDERWENT AN INITIAL REVISION SURGERY DUE TO AN UNKNOWN REASON APPROXIMATELY EIGHT (8) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO THE IMPLANT DISASSOCIATING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AND FOUR MONTHS AGO. THE PATIENT UNDERWENT AN INITIAL REVISION SURGERY DUE TO AN UNKNOWN REASON APPROXIMATELY EIGHT (8) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO THE IMPLANT DISASSOCIATING. THE PATIENT WAS EXPERIENCING PAIN AND ROM ISSUES.