BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 11954498 · Received June 8, 2021

    Report

    Report Number
    3006946279-2021-00089
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 26, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP IS TO RELAY ADDITIONAL INFORMATION. THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO OTHER COMPLAINT ON MEDICAL: REVISION - PAIN - LOOSENING - INSTABILITY WAS RECORDED ON THE BATCH SINCE EVER, AND 4 OTHER COMPLAINTS ON MEDICAL: REVISION; PAIN; LOOSENING; INSTABILITY WAS RECORDED FROM (B)(6) 2018 TO (B)(6) 2021. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE DUE TO LOOSE TIBIA, PAIN AND INSTABILITY.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). REPORT SOURCE, HEALTH PROFESSIONAL - EVENT OCCURRED IN UNITED STATES OF AMERICA. LIST OF ASSOCIATED PRODUCTS : ITEM NUMBER : 96-0100 - ITEM NAME : OVAL DOME PATELLA 3-PEG - LOT : D19072003. ITEM NUMBER : 96-0013 - ITEM NAME : FEMORAL CRUCIATE RETAINING CEMENTED SIZE 3 RIGHT - LOT : D19090535. ITEM NUMBER : 1581-30-000 - ITEM NAME : TIBIAL TRAY FIXED BEARING MOD COCR - LOT : 9285147. ITEM NUMBER : 1581-13-108 - ITEM NAME : TIBIAL INSERT FIXED BEARING CURVED - LOT : 9299157. ITEM NUMBER : AR-1927BCF-3 - ITEM NAME : SUTURE ANCHOR BIOCOMPOSITE CORKSCREW FT TRIPLEPLAY VENTED - LOT : 10319263. 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 A PATIENT UNDERWENT A REVISION TOTAL KNEE DUE TO LOOSE TIBIA, PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850813 BIOMET BC R 1X40 US ORTHOPAEDIC CEMENT, MEDICATED LOD BIOMET FRANCE S.A.R.L. 842HAH1403 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 FOR ASSOCIATEDPRODUCTS.