BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 117854 · Received September 3, 1997

    Report

    Report Number
    33141-1997-00005
    Event Type
    Injury
    Date Received
    September 3, 1997
    Date of Event
    August 28, 1997
    Report Date
    September 2, 1997
    Manufacturer
    ZIMMER, INC
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN. IT WAS FOUND THAT THE PLASTIC HAD SEPARATED FROM THE METAL. THE MG I PATELLA WAS REPLACED WITH A 00-5220-014-00. THE MG I PATELLA WAS A WHITE POROUS IMPLANT. THE HOSPITAL RELEASED THE DEVICE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant MG PATELLA HTG ZIMMER, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention