ULTRA DRIVE 180MM TIP EXTENDER

Additional Manufacturer Narrative

(B)(4). 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 ULTRA DRIVE TIP EXTENDER KEPT BREAKING DURING THE CASE. THERE WAS A FORTY (40) MINUTE DELAY TO THE PROCEDURE AS A RESULT. NO ADDITIONAL PATIENT CONSEQUENCES WERE NOTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT ULTRA DRIVE EXTENDER BREAKAGE OCCURRED WHILE TRYING TO REMOVE CEMENT AFTER FEM STEM WAS REMOVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE VISUAL INSPECTION IDENTIFIED NUMEROUS GOUGES & CONTACT DEFORMATIONS ON THE PROXIMAL WRENCH FLATS. SEM REPORT CONFIRMED THE FRACTURE NEAR THE DISTAL TIP, AND AN AREA WAS IDENTIFIED BENT OUTWARD, SUGGESTING THE FORCES THAT LIKELY CAUSED THE FRACTURE MAY HAVE OCCURRED NEAR THE TIME THE BENDING OCCURRED. ARTIFACTS OF THE DISTAL TIP¿S FRACTURE SURFACE DEMONSTRATED FATIGUE FRACTURES WITH POSSIBLE MULTIPLE ORIGINS. DEFORMATION WAS IDENTIFIED ON THE INNER THREADS OF DISTAL TIP. HOWEVER, IT COULD NOT BE DETERMINED IF THE DEFORMATION OCCURRED BEFORE THE FRACTURE OR AFTER. ROOT CAUSE WAS 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.