E-POLY 40MM +3 HIWALL LNR SZ24

Additional Manufacturer Narrative

(B)(4). 51-106150, TPRLC 133 MICROPLASTY TYPE1 PPS SO 15.0, 2911786; 13-104156, M/H 3HOLE RINGLOC SHELL NRS 56MM/L24, 578430; S001140, SELEX/MAGNUM MOD HD 40MM STD, 670290. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02535, 0001825034 - 2018 - 02534, 0001825034 - 2018 - 02537.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED 0.5 YEARS POST IMPLANTATION DUE TO CHRONIC INFECTION, SEVERE PAIN, DISLOCATION, METALLOSIS, COMPONENT LOOSENING, AND LACK OF MOBILITY. ALL OF THE COMPONENTS WERE REVISED AND ANTIBIOTIC SPACERS WERE PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED 0.5 YEARS POST IMPLANTATION DUE TO CHRONIC INFECTION, SEVERE PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE,DISLOCATION, METALLOSIS, COMPONENT LOOSENING, AND LACK OF MOBILITY. PSEUDOCAPSULE DISSECTED WITH PURULENT DRAINAGE WERE NOTED. ALL OF THE COMPONENTS WERE REVISED AND ANTIBIOTIC SPACERS WERE PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVISION OP NOTES DATED 16 JAN 2014 WAS REVIEWED AND IT WAS IDENTIFIED THE PATIENT WAS REVISED DUE TO STAGE ONE CHRONIC HIP INFECTION. REVISION OP NOTES DATED 28 AUG 2014 WERE REVIEWED AND IT WAS IDENTIFIED THE PATIENT WAS REVISED DUE TO STAGE TWO CHRONIC HIP INFECTION. RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED 0.5 YEARS POST IMPLANTATION DUE TO CHRONIC INFECTION, SEVERE PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE,DISLOCATION, METALLOSIS, COMPONENT LOOSENING, AND LACK OF MOBILITY. PSEUDOCAPSULE DISSECTED WITH PURULENT DRAINAGE WERE NOTED. ALL OF THE COMPONENTS WERE REVISED AND ANTIBIOTIC SPACERS WERE PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.