BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 90731 · Received May 10, 1997

    Report

    Report Number
    33458-1997-00003
    Event Type
    Injury
    Date Received
    May 10, 1997
    Date of Event
    May 7, 1997
    Report Date
    May 9, 1997
    Manufacturer
    ZIMMER
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UHMPE SEPARATED FROM METAL BACKING ON PATELLA COMPONENT. THE FOLLOWING COMPONENTS WERE ALSO REPLACED: FEMORAL 5780-012, LOT# 007356, ART SURFACE, 5780-050-11, LOT 528939. HOSP GAVE IMPLANTS TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant MILLER GALANTE POROUS PATELLAR DOME HTG ZIMMER NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention