BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUAR PS TIBIAL BEARING 10X71/75MM

    MDR report key: 6486770 · Received April 12, 2017

    Report

    Report Number
    0001825034-2017-02513
    Event Type
    Injury
    Date Received
    April 12, 2017
    Report Date
    May 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. AN ADDITIONAL MDR REPORT WAS FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0009610576-2017-00015.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CONCOMITANT MEDICAL PRODUCTS: BIOMET VANGUARD PS OPEN INTL FEM-LT 70, CATALOG: 183132, LOT: 702110; BIOMET POLISHED FINNED TIB TRAY 75MM, CATALOG: 141254, LOT: 2016050100; BIOMET SIG TKA GDE/MDL SET 04-05, CATALOG: 42-422561, LOT: 170540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOCKING BAR NOT SEATING CORRECTLY. THERE WERE NO DELAYS OR COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268518 VANGUAR PS TIBIAL BEARING 10X71/75MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 227540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R