BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM A/P LIPPED TIBIAL INSER

    MDR report key: 350494 · Received August 30, 2001

    Report

    Report Number
    2219689-2001-00134
    Event Type
    Malfunction
    Date Received
    August 30, 2001
    Report Date
    August 3, 2001
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    HSH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT WOULD NOT FIT ONTO THE BASEPLATE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39620 MEDIUM A/P LIPPED TIBIAL INSER IMPLANT HSH HOWMEDICA OSTEONICS NA XCWMA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other