BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD AS TIB BRG 18X83

    MDR report key: 12342616 · Received August 19, 2021

    Report

    Report Number
    0001825034-2021-02471
    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
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    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. VISUAL EXAMINATION OF THE RETURNED BEARING FOUND SIGNS OF WEAR AND DEEP GOUGES/NICKS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND PATIENT PRESENT WITH SIGNIFICANT PAIN. MRI IDENTIFIED OSTEOLYSIS UNDER THE MEDIAL FEMORAL IMPLANT. REVISION SURGERY FOUND THE FEMORAL IMPLANT FRACTURED WITH METALLOSIS IN THE SYNOVIAL TISSUES. TIBIAL IMPLANT REMAINED INTACT. CYST PRESENT IN THE MEDIAL FEMORAL CONDYLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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; UNKNOWN - UNKNOWN TIBIAL COMPONENT - UNKNOWN. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001825034-2021-02470, 0001825034-2021-02472.

    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
    1239998 E1 VNGD AS TIB BRG 18X83 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 519400

    Patients

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