BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING 10MM X 63/67MM

    MDR report key: 6240760 · Received January 11, 2017

    Report

    Report Number
    0001825034-2017-00136
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    March 18, 2016
    Report Date
    January 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS DEVICE IS USED FOR TREATMENT ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. VANGUARD LEFT FEMORAL 62.5 MM, CATALOG 183066, LOT 216290; BIOMET 67MM FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR, CATALOG 141232 LOT 424220; BIOMET SERIES A STANDARD PATELLA 31MM X 8.0MM, CATALOG 184764, LOT 724120. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT/PATIENT* (REFERENCE 1825034-2017-00136 / 00139).

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A LEFT KNEE REVISION APPROXIMATELY NINE YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE PROCEDURE WAS CANCELLED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24910 VANGUARD DCM CR TIBIAL BEARING 10MM X 63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 436230

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention