BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT PSL MICROSTRUCTURED

    MDR report key: 256408 · Received December 21, 1999

    Report

    Report Number
    2243265-1999-00092
    Event Type
    Injury
    Date Received
    December 21, 1999
    Report Date
    December 21, 1999
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION HIP REPLACEMENT IN 1999 EXCHANGED FOR ANOTHER COMPONENT AND FEMORAL HEAD. PROSTHESIS WAS PLACED IN PT AT HOSP IN 1995, AGE 58 YRS, MALE. PT DID NOT RETURN FOR ANNUAL APPOINTMENT DUE 1/11/1996. DOING WELL- WORKED IN NURSERY - MUCH BENDING AND LIFTING. (L) HIP REPLACED AT SOME TIME. DOING WELL WITH NO LYSIS. UNABLE TO WALK WITHOUT SUPPORT. MIGRATION WITH SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT PSL MICROSTRUCTURED Implant IMPLANT KWB HOWMEDICA INC. NA LV3023

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention