BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY TOTAL ELBOW REPLACEMENT SET BUSHINGS & PINS

    MDR report key: 1242225 · Received November 19, 2008

    Report

    Report Number
    1822565-2008-00810
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO X-RAYS WERE PROVIDED TO VISUALLY EXAMINE THE STATED ISSUE AND CONFIRM THAT FULL ASSEMBLY OF THE PINS DID OCCUR DURING THE INITIAL SURGERY. NO LOT NUMBER WAS PROVIDED. THE PINS MEET BLUEPRINT SPECIFICATION. DUE TO INSUFFICIENT INFORMATION THE CAUSE CAN NOT BE DEFINITELY DETERMINED. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SCANNING ELECTRON MICROSCOPY ANALYSIS (SEM) / ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008. THE HINGE PIN WAS DISENGAGED WHEN SURGEON WAS PERFORMING I&D OF PATIENT'S ELBOW. PIN MECHANISM WOULD GO BACK TOGETHER. IT DID NOT APPEAR TO BE BROKEN BUT, IT COULD BE EASILY PULLED A PART AGAIN. IT WAS NOT STAYING LOCKED. IMPLANT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW REPLACEMENT SET BUSHINGS & PINS ELBOW PROSTHESIS JDC ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R