BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISH FINNED TIBIAL TRAY 63MM

    MDR report key: 6301687 · Received February 3, 2017

    Report

    Report Number
    0001825034-2017-00381
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    September 23, 2016
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. VANGUARD PS TIBIAL BEARING CATALOG 183620 LOT 116140; VANGUARD PS FEMORAL CATALOG 183124 LOT 961460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SIX MONTHS POST IMPLANTATION DUE TO PAIN, DIFFICULTY MOBILIZING, AND THE FORMATION OF AN UNKNOWN DARK SPOT NEAR THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84454 POLISH FINNED TIBIAL TRAY 63MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 2013010375

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R