BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVEN KNEE COMPONENT

    MDR report key: 314099 · Received January 25, 2001

    Report

    Report Number
    2530191-2001-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2001
    Date of Event
    January 15, 2001
    Report Date
    January 25, 2001
    Manufacturer
    STELKAST CO
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 22 MONTHS OF IMPLANT, THE LEFT PATELLA WAS EXPLANTED BECAUSE SHEAR STRESS CAUSED THE CEMENT MANTLE TO FAIL. THE IMPLANT WAS NOT RETURNED; HOWEVER, IT WAS REPORTED THAT SOME AMOUNT OF CEMENT WAS LEFT ON THE BACK SIDE OF PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3092 PROVEN KNEE COMPONENT KNEE / PATELLA HTG STELKAST CO 3 PEG PATELLA 1932

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention