ARCOS 3.5MM HEX DRIVE

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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G4; H2.

Additional Manufacturer Narrative

COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. UPON VISUAL INSPECTION THE HEX DRIVE HAD FRACTURED WITH NO OTHER DAMAGE VISIBLE. XRF ANALYSIS FOUND THE HEX DRIVER MATERIAL TO BE CONSISTENT WITH 440 STAINLESS STEEL ALLOY. FRACTURE SURFACE ARTIFACTS INDICATE BENDING OVERLOAD FRACTURE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO 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). CONCOMITANT MEDICAL PRODUCTS: 31-301856, ARCOS TAPER DISASSEMBLY, ZB160202. 31-301870, ARCOS ANTI TORQUE HANDLE, ZB1151101. UNKNOWN ARCOS PROXIMAL BODY, UNKNOWN PART AND LOT. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 DURING A HIP REVISION OF COMPETITOR¿S PRODUCT, THE SURGEON WAS ADJUSTING THE VERSION OF THE PROXIMAL BODY OF THE STEM. IN AN ATTEMPT TO ADJUST THE STEM COMPONENT, THE INSTRUMENTS BROKE. NO FRACTURED PIECES WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.