BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL COMPONENET

    MDR report key: 12342614 · Received August 19, 2021

    Report

    Report Number
    0001825034-2021-02472
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    August 4, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 183074 - VANGUARD CR POR FMRL-LT 75 - 260130; EP-189128 - E1 VNGD AS TIB BRG 18X83 - 519400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2021-02470, 0001825034-2021-02471.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE LEFT TOTAL KNEE ARTHROPLASTY APPROXIMATELY 8 YEARS AFTER INITIAL IMPLANTATION FOR MEDIAL PAIN AND OSTEOLYSIS. INTRAOPERATIVELY, A FEMORAL IMPLANT FRACTURE, METALLOSIS IN THE SYNOVIAL TISSUE, AND A RECURRING MEDIAL FEMORAL CONDYLE CYST WERE ENCOUNTERED. THE SYNOVIUM WAS REMOVED, THE BONE DEFECT FROM THE CYST FILLED, AND BOTH FEMORAL AND TIBIAL COMPONENTS WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239993 UNKNOWN TIBIAL COMPONENET PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10.