BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 9652496 · Received January 31, 2020

    Report

    Report Number
    0001825034-2020-00460
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304009738
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HCP, BUT DID NOT NOTE ANY PAIN OR MOBILITY ISSUES POST IMPLANTATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE 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. CONCOMITANT MEDICAL PRODUCTS: 184508, FEMORAL COMPONENT, LOT # 318040; 141314, FINNED PRI STEM, LOT # 255700; 141273, TIBIAL TRAY, LOT # 834180; 184764, PATELLA, LOT # 470450; EP-183640, BEARING, LOT # 464570. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04681, 0001825034-2019-04682, 0001825034-2019-04684, 0001825034-2019-04694, 0001825034-2019-04688.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST REVISION, THE PATIENT HAS CONTINUED TO HAVE PAIN AND DIFFICULTY WITH AMBULATION INTERFERING WITH DAILY LIFE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119289 BIOMET TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 884630 00880304009738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other