BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY PIN/BUSHING REPLACEMENT KIT

    MDR report key: 2023273 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00622
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED, THE TINES OF THE COONRAD/MORREY INNER PIN HAVE FRACTURED APPROXIMATELY ONE YR POST-OPERATIVELY. MFG DOCUMENTATION FOR THIS LOT HAS BEEN REVIEWED AND INDICATES THAT THE DEVICE WAS MFG, INSPECTED AND PACKAGED TO SPECIFICATION. THE PRODUCT EXPERIENCE REPORT INDICATES THE PT HAS A HIGH ACTIVITY LEVEL. THE ZIMMER "COONRAD/MORREY TOTAL ELBOW" BOOKLET INCLUDED WITH THE IMPLANT STATES THAT THE PT MUST NOT LIFT MORE THAN FIVE POUNDS WITH THE OPERATED ARM. THE PT'S HIGH ACTIVITY LEVEL MAY HAVE LED TO INCREASED WEAR AND OVER LOADING OF COMPONENTS. SURGICAL NOTES AND X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WITH THE INFO PROVIDED A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S ELBOW BUSHING HAD FAILED AND REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY PIN/BUSHING REPLACEMENT KIT JDC ZIMMER, INC. 61172429

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention