VERSYS ENHANCED TAPER 15X140

Additional Manufacturer Narrative

(B)(4). D10: CAT #: 0100181480 / METASUL® LDH®, HEAD, 48, CODE N, TAPER 18/20 / LOT #: 2481321. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY FIFTEEN YEARS POST IMPLANTATION DUE AN IMPLANT FRACTURE. THE STEM AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. CORRESPONDENCE TALKS OF A ¿FRACTURE IN A PATIENT WITH MOM PRODUCTS¿, BUT THEY DO NOT SAY THAT THE PRODUCTS THEMSELVES FRACTURED IN ANY WAY. THEREFORE, WE HAVE NO INDICATION THAT THE FRACTURE TOOK PLACE AROUND THE PRODUCTS (AS FOR EXAMPLE A PERIPROSTHETIC FRACTURE MIGHT BE), BUT ONLY THAT A PATIENT WITH MOM SYSTEM HAD A GENERIC FRACTURE. THIS WAS FURTHER CONFIRMED THROUGH ADDITIONAL FOLLOW-UP, AS SEEN IN THE ATTACHED EMAIL, WHERE STATED THAT "THE FRACTURES ARE NOT RELATED TO THE DEVICE". BASED ON THE RECEIVED INFORMATION, IT CAN BE CONCLUDED THAT THE DEVICE REPORTED IN THIS COMPLAINT IS NOT RELATED TO THE INITIAL ALLEGATION. THIS COMPLAINT CANNOT BE CONFIRMED. 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 INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.