BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM PS TIBIBAL BEARING 14MM X 71/75MM

    MDR report key: 6323917 · Received February 10, 2017

    Report

    Report Number
    0001825034-2017-00600
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    September 13, 2011
    Report Date
    March 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO RELAY CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS- FEMORAL CATALOG 183128 LOT 122160; TIBIAL TRAY CATALOG 141233 LOT 191920; PATELLA CATALOG 11-150842 LOT 107970.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR PN:183644 LN:305420 IDENTIFIED NO DEVIATIONS OR ANOMALIES. -THIS DEVICE IS USED FOR TREATMENT. -ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. -NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT CONCOMITANT PRODUCT(S): - FEMORAL, CATALOG 183128, LOT 282250; TIBIAL TRAY, CATALOG 141233, LOT 179540; PATELLA, CATALOG 11-150842, LOT 138240.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A STEROID INJECTION IN THE RIGHT KNEE APPROXIMATELY FIVE YEARS POST TOTAL KNEE ARTHROPLASTY DUE TO IT BAND TENDONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107138 VANGUARD DCM PS TIBIBAL BEARING 14MM X 71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 305420

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other