28MM DIA COCR MOD HD -6MM NK

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON DUE TO INFECTION. THE LINER, BEARING, AND HEAD WERE EXCHANGED. THE STEM AND SHELL REMAIN IMPLANTED. NO OPERATIVE RECORDS PROVIDED. UPON RECEIPT OF THE STERILE CERT FOR THIS DEVICE, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT A CONTRIBUTING FACTOR OF THE REPORTED EVENT AND THIS REPORT CAN THEREFORE BE VOIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H4, H11. UPON RECEIPT OF THE STERILE CERT FOR THIS DEVICE, IT WAS DETERMINED THAT THIS PRODUCT WAS NOT A CONTRIBUTING FACTOR OF THE REPORTED EVENT AND THIS REPORT CAN THEREFORE BE VOIDED. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON DUE TO INFECTION. THE LINER, BEARING, AND HEAD WERE EXCHANGED. THE STEM AND SHELL REMAIN IMPLANTED. NO OPERATIVE RECORDS PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: 110024465 G7 DUAL MOBILITY LINER 46MM G 66816126. 010000667 G7 PPS LTD ACET SHELL 60G 7504836. 110031013 VIVACIT-E DM BEARING 28X46MM UNK. G2: FOREIGN: DENMARK. SUGGESTED COMPONENT CODE- MECHANICAL (G04): HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.