BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAX BI-POLAR CUP 32X54MM

    MDR report key: 135526 · Received November 26, 1997

    Report

    Report Number
    2219689-1997-00677
    Event Type
    Malfunction
    Date Received
    November 26, 1997
    Date of Event
    October 23, 1997
    Report Date
    November 25, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WOULD NOT ARTICULATE INSIDE THE CENTRAX BI-POLAR CUP. A 1MM SMALLER O.D. PROSTHESIS WAS USED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAX BI-POLAR CUP 32X54MM Implant IMPLANT KWB HOWMEDICA INC. NA SFKCAA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other