BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COONRAD/MORREY TOTAL ELBOW PIN/BUSHING REPLACEMENT KIT SMALL

    MDR report key: 1310239 · Received December 8, 2008

    Report

    Report Number
    1822565-2008-00885
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DOES NOT STATE WHETHER OR NOT THE SECOND KIT USED WAS THE SAME ITEM NUMBER. NO ITEM NUMBERS OF THE PREVIOUSLY IMPLANTED STEMS WERE PROVIDED. X-RAYS WERE NOT RETURNED FOR EVALUATION. THE COMPLAINT INDICATES THAT THE ELBOW WAS SMALL. THERE ARE DIFFERENT REVISION BUSHING KITS FOR THE VARIOUS COMBINATIONS OF IMPLANT STEMS, AS NOTED IN THE SURGICAL TECHNIQUE. BASED ON THE INFORMATION PROVIDED, THE EXACT CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHEN THE SURGEON TRIED TO IMPLANT THE REPLACEMENT KIT, IT WOULD NOT FIT. IT WAS REPORTED THE ELBOW WAS A SIZE SMALL. ANOTHER REPLACEMENT KIT WAS OPENED, WHICH WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW PIN/BUSHING REPLACEMENT KIT SMALL EXTREMITY PROSTHESIS KWJ ZIMMER, INC. NA 60996790

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR