EXPLOR 10X22MM IMPLANT HEAD

Additional Manufacturer Narrative

(B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 11-210061, EXPLOR 6X24MM IMPL STEM W/SCR, LOT # 508660. G2: NORWAY. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD LOOSENING OF THE HEAD COMPONENT IN RELATION TO RADIAL STEM WITH 2MM LATERALIZATION AND SCREW LOOSENING. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). UPDATED: B1, B4, B5, D2, D4 (EXP DATE, UDI), G3, H1, H2, H3, H4, H6, H11. MECHANICAL (G04) - HEAD. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY APPROXIMATELY 9 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD DISASSOCIATION OF THE HEAD IN RELATION TO THE STEM ABOUT 7 MONTHS AGO. THERE WAS NO TREATMENT GIVEN AS OF NOW AND NONE PLANNED.

Additional Manufacturer Narrative

(B)(4). 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 9 YEARS AGO. PATIENT WAS ALSO NOTED TO HAVE MODERATE ARTHROSIS GLOBALLY. NO INTERVENTION IS PLANNED TO DATE.