EXPLOR 9X30MM IMPL STEM W/SCR

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND CREPITATION IN ELBOW AT APPROXIMATELY 2.5 YEARS POST OP. RADIOLOGY SHOWED LOOSENING OF THE STEM AND THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 11-210043, EXPLOR 14X24 MM IMPLANT HEAD, LOT # 572570 G2: NORWAY H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

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

Additional Manufacturer Narrative

(B)(4). PROPOSED G-CODE: MECHANICAL (G04) - STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

Additional Manufacturer Narrative

(B)(4). UPDATED: B4, B5, D2, D4 (EXP DATE), D6A, G3, H1, H2, H4, H11. 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 FURTHER REPORTED THAT THE INITIAL SURGERY WAS PERFORMED APPROXIMATELY 11 YEARS AGO.