EXPLOR 7X26MM IMPL STEM W/SCR

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: POLAND. D10 NARRATIVE: ITEM: 11-210042, LOT: 895100, ITEM NAME: EXPLOR 12X24 MM IMPLANT HEAD. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) -STEM. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: POLAND. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - STEM. D10 NARRATIVE: ITEM: 11-210042. LOT: 895100. ITEM NAME: EXPLOR 12X24 MM IMPLANT HEAD. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 (A, E, F CODE), D6B (DEVICE WAS NOT EXPLANTED). THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE STEM. THE REPORTED EVENT IS NOT CONFIRMED. 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

IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL ELBOW PROCEDURE APPROXIMATELY 1 YEAR AGO AND IS BEING CONSIDERED FOR A REVISION PROCEDURE DUE TO THE LOOSENING OF THE STEM COMPONENT. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFO IS AVAILABLE AT THE TIME OF THIS REPORT.