BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MTK TIB/INS LARGE 9 RIGHT

    MDR report key: 216823 · Received March 30, 1999

    Report

    Report Number
    2219689-1999-00072
    Event Type
    Injury
    Date Received
    March 30, 1999
    Date of Event
    March 25, 1996
    Report Date
    March 29, 1999
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ON 01/15/1991, THE PT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT, THE SURGEON IMPLANTED A HOWEDICA P.C.A. TIBIAL INSERT. ON 03/25/96 THE PATIENT UNDERWENT A REVISION SURGERY ON THE SAME KNEE TO REMOVE THE INSERT THAT HAD REPORTEDLY WORN. THE SURGEON IMPLANTED ANOTHER HOWEDICA P.C.A. TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MTK TIB/INS LARGE 9 RIGHT Implant IMPLANT HSH HOWMEDICA INC. NA TNHRA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention