BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOENIG IMPLANT

    MDR report key: 34002 · Received June 12, 1996

    Report

    Report Number
    34002
    Event Type
    Injury
    Date Received
    June 12, 1996
    Date of Event
    June 4, 1996
    Report Date
    June 12, 1996
    Manufacturer
    UNKOWN
    Product Code
    LZJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD 1ST MTPJ SURGERY ON 7/8/93 WITH IMPLANT PLACEMENT. ON 10/24/94 SHE WAS READMITTED FOR REMOVAL OF THE DISTAL PORTION OF THE IMPLANT DUE TO IMPLANT FAILURE AFTER SHE SUFFERED TRAUMA TO THE AREA. THIS SURGERY LEFT HER WITH A "KELLER" TYPE BUNION PROCEDURE AND SHE DID WELL UNTIL ONE MONTH LATER. HER SHOE RUBBED AGAINST THE IMPLANT, PAIN RETURNED AND HAS REMAINED CONSTANT. HER FOOT HAS BEEN STEPPED ON SEVERAL TIMES AS WELL AS BUMPING IT AGAINST OBJECTS. HAVE TRIED CONSERVATIVE APPROACH. SURGERY ON 6/4/96 FOR REMOVAL METATARSAL IMPLANT RIGHT FOOT. POST OP DX. SESAMOIDITIS AND NEURITIS WITH ASSOCIATED INTERMETATARSAL BURSAE Z DEGREES. IMPLANT FAILURE RIGHT 1ST MTPJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOENIG IMPLANT Implant METATARSAL IMPLANT LZJ UNKOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R