ARCOS 18X190MM SPL TPR DIST M

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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A LONGITUDINAL PERIPROSTHETIC FRACTURE OF THE FEMORAL DIAPHYSIS EXTENDING TO THE TIP OF THE FEMORAL IMPLANT. ON THE LATERAL VIEW, THE IMPLANT EXTENDS BEYOND THE POSTERIOR CORTICAL MARGIN OF THE FEMUR. BONE QUALITY IS MARKEDLY OSTEOPENIC. THE FEMORAL IMPLANT IS LOOSE SECONDARY TO THE PERIPROSTHETIC FRACTURE. IT IS UNKNOWN IF THE LOOSENING HAPPENED PRIOR OR AFTER THE FRACTURE. 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. 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). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 1 WEEK LATER DUE TO A FEMUR FRACTURE. THE SURGEON STATED THAT THE ORIGINAL ARCOS STEM HAD PENETRATED AND FRACTURED THE BACK WALL OF THE FEMUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.