EXPLOR MODULAR RADIAL STEM WITH SCREW

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW IMPLANTATION APPROXIMATELY ONE (1) YEAR AGO AFTER EXPERIENCING AN ISOLATED, COMMINUTED FRACTURE OF THE RADIAL HEAD TWO (2) DAYS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE RADIAL HEAD PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: ITEM# 11-210032; LOT# 311110. E1: FULL ESTABLISHMENT NAME - (B)(6). G2: FOREIGN - EVENT OCCURRED IN POLAND. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.