BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON ANT CONS TIB INS 11MSM

    MDR report key: 171227 · Received June 4, 1998

    Report

    Report Number
    2219689-1998-00336
    Event Type
    Injury
    Date Received
    June 4, 1998
    Date of Event
    May 13, 1998
    Report Date
    June 4, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: EVAL CANNOT BE PERFORMED ON THE EVENT INSERT, BUT EVAL ON THE INSERT FROM STOCK SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REPORTER STATES THAT PT COMPLAINED OF POST-OP RETRO PATELLAR PAIN. SURGEON WENT TO SCOPE T/K TO IDENTIFY SOURCE OF PAIN. UPON SCOPING TIBIAL INSERT WAS SHOWN TO HAVE MOVEMENT BETWEEN 4-5MM (LIFT OFF) FROM TIBIAL BASEPLATE. SURGEON THEN OPENED THE KNEE AND CURRENT INSERT WAS REPLACED WITH A NEW IMPLANT (INSERT). NEW IMPLANT SNAPPED IN WITH NO DIFFICULTY. SAME THICKNESS WAS IMPLANTED AS PRIMARY SURGERY. NO INSTABILITY WAS NOTED AT TIME OFF REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON ANT CONS TIB INS 11MSM Implant IMPLANT HSH HOWMEDICA INC. NA UYRRA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention