BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAX BI-POLAR CUP 32X60MM

    MDR report key: 137985 · Received December 13, 1997

    Report

    Report Number
    2219689-1997-00724
    Event Type
    Malfunction
    Date Received
    December 13, 1997
    Date of Event
    October 12, 1997
    Report Date
    December 12, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: THE EVALUATION RESULTS VERIFIED THIS REPORTED EVENT. A DESIGN CHANGE WAS INCORPORATED IN 09/1996 TO REDUCE OR ELIMINATE THIS "SNUG" CONDITION.

    Description of Event or Problem · 1

    THE HEAD WILL NOT ROTATE IN THE CUP. ANOTHER IMPLANT WAS AVAILABLE AND WAS USED INSTEAD. 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
    1 CENTRAX BI-POLAR CUP 32X60MM Implant IMPLANT KWB HOWMEDICA INC. NA PLPTCA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other