UNKNOWN SCREW

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS NO IMPLANT LOOSENING. THERE IS RADIAL HEAD IMPLANT SCREW DISPLACEMENT AND MILD OFFSET AT THE IMPLANT ARTICULATION AS NOTED WITHOUT GROSS DISASSEMBLY. ALIGNMENT OF THE ELBOW IS OVERALL MAINTAINED. SCREW DISPLACEMENT FROM THE RIGHT ELBOW RADIAL HEAD IMPLANT AS NOTED WITH SLIGHT OFFSET AT THE ARTICULATION OF THE TWO COMPONENTS. A DEFINITIVE ROOT CAUSE CANNOT 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

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

Additional Manufacturer Narrative

(B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN EXPLOR RADIAL HEAD; LOT#: UNKNOWN. G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT 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 UNDERWENT AN INITIAL RIGHT ELBOW ARTHROPLASTY APPROXIMATELY ONE (1) AND A HALF YEARS AGO. SUBSEQUENTLY, THE PATIENT IS REPORTING STIFFNESS, PAIN, AND LOSS OF RANGE OF MOTION THAT IS DUE TO THE SCREW LOOSENING. THE PATIENT IS BEING PLANNED FOR A REVISION SURGERY THAT THE DATE HAS YET TO BE SCHEDULED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.