BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLER GALANTE TOTAL KNEE

    MDR report key: 16715 · Received January 28, 1994

    Report

    Report Number
    16715
    Event Type
    Injury
    Date Received
    January 28, 1994
    Date of Event
    December 10, 1993
    Report Date
    December 17, 1993
    Manufacturer
    ZIMMER
    Product Code
    MBV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON 10/20/88. PATIENT COMPLAINED OF PAIN FOR SEVERAL MONTHS. SURGICAL INTERVENTION ON 12/10/93 REVEALED POLYETHELENE (UHMWPE) PORTIONOF TOTAL KNEE PATELLA COMPONENT BROKE AWAY FROM ITS METAL BACKING. POLYETHYLENE DEBRIS WAS ALSO PRESENT INT HE WOUND AS WELL AS BLACKENED SYNOVIUM WHICH WAS FELT BY THE SURGEON TO BE A METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER GALANTE TOTAL KNEE Implant PATELLAR DOME MBV ZIMMER 62115500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 * Hospitalization| R