BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INLAY SIZE 44 22,2

    MDR report key: 11377511 · Received February 25, 2021

    Report

    Report Number
    3006946279-2021-00020
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    July 28, 2020
    Report Date
    May 28, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (REMAINS IMPLANTED). THE DEVICE MANUFACTURING QUALITY RECORD INDICATES THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. RESULTS FROM MICROBIOLOGY ANALYSIS WERE RECEIVED, AND ALLOWED TO CONFIRM THE REPORTED INFECTION. ACCORDING TO THESE RESULTS, THEREPORTED EVENT WAS DUE TO BACTERIAL INFECTION TO STAPHYLOCOCCUS EPIDERMIDIS, WHICH IS A NORMAL COLONIZER OF THE SKIN. COMPLAINT EXTRACT WAS DONE REGARDING MEDICAL INFECTION: 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON AVANTAGE INLAY S44 / 22,2, REFERENCE (B)(4), FROM 01-JAN-2018 TO 26-MAR-2021. 1 COMPLAINT (1 PRODUCT), THIS ONE INCLUDED, HAS BEEN RECORDED ON AVANTAGE INLAY S44 / 22,2, REFERENCE P0560044, BATCH 0001439499, SINCE EVER. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO BACTERIAL INFECTION TO STAPHYLOCOCCUS EPIDERMIDIS, WHICH IS A NORMAL COLONIZER OF SKIN.THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO THE PRODUCT. THE COMPLAINT IS CLOSED BUT COULD BE REOPENED IF NEW INFORMATION IS RECEIVED LATER. 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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10- LIST OF ASSOCIATED DEVICES: AVANTAGE RELOAD CUP TI HA S44; ITEM #P0460P44; LOT # 0001219576; MANUFACTURED BY ZB VALENCE. EXCEPTION STD STEM LEFT SIZE 1; ITEM #PS125Y01; LOT #0001270155; MANUFACTURED BY ZB VALENCE. COCR FM HD D22,2/ 12-14/ +2/ L ; ITEM #P0206L22; LOT #J6382918; MANUFACTURED BY ZB VALENCE. THE DEVICE MANUFACTURING QUALITY RECORDS ALL INDICATE THAT THE RELEASED PRODUCTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVED ON (B)(6) 2020 AT THE CLINIC AND UNDERWENT ON (B)(6) 2020. A CLEANING AND WASHING OF THE JOINT FOLLOWING A BACTERIAL INFECTION TO STAPHYLOCOCCUS EPIDERMIDIS, WHICH IS A NORMAL COLONIZER OF SKIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVED ON (B)(6) 2020 AT THE CLINIC AND UNDERWENT ON (B)(6) 2020 A CLEANING AND WASHING OF THE JOINT FOLLOWING A BACTERIAL INFECTION TO STAPHYLOCOCCUS EPIDERMIDIS, WHICH IS A NORMAL COLONIZER OF SKIN.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOLLOWING AN UNSPECIFIED INFECTION. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277194 AVANTAGE INLAY SIZE 44 22,2 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER KWA BIOMET FRANCE S.A.R.L. 0001439499

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R ASSOCIATED DEVICES LISTED IN SECTION H10.