BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAX BI-POLAR CUP 32X52MM

    MDR report key: 148373 · Received February 5, 1998

    Report

    Report Number
    2219689-1998-00070
    Event Type
    Malfunction
    Date Received
    February 5, 1998
    Report Date
    February 4, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: THE EXAMINATION RESULTS VERIFIED THE REPORTED EVENT. A DESIGN CHANGE WAS INCORPORATED IN 09/1996 TO REDUCE OR ELIMINATE THIS "SNUG" CONDITION. THE COMPONENT OF THIS EVENT WAS MANUFACTURED IN 07/1992.

    Description of Event or Problem · 1

    IT WAS HARD TO MOVE THE HEAD WITHIN THE BIPOLAR CUP. ANOTHER CUP WAS AVAILABLE AND WAS USED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAX BI-POLAR CUP 32X52MM Implant IMPLANT KWB HOWMEDICA INC. NA ARDMBA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other BG UNIVERSAL HEAD - CAT. NO. 4655-00