BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY TOTAL ELBOW HUMERAL ASSEMBLY

    MDR report key: 2210619 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01836
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    May 23, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: AS RETURNED, THE TINES OF THE INNER PIN HAVE FRACTURED AND WERE NOT RETURNED. IT IS POSSIBLE THAT THE FRACTURE OF THE PIN WAS CAUSED BY THE PT NOT FOLLOWING THE RECOMMENDATIONS IN THE ZIMMER (B)(4) TOTAL ELBOW BOOKLET INCLUDED WITH THE IMPLANT, WHICH STATES THAT THE PT MUST NOT LIFT MORE THAN FIVE POUNDS WITH THE OPERATED ARM. THE DESIGN OF THE PIN HAS BEEN IMPROVED TO POTENTIALLY REDUCE THE LIKELIHOOD OF FAILURE IN CASES THE DEVICE IS USED OUTSIDE OF RECOMMENDATIONS. THE DEVICE IN THIS CASE WAS MANUFACTURED PRIOR TO THIS NEW DESIGN. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. INNER AND OUTER PIN MEET PRINT SPECIFICATION WHERE MEASURED. THE INNER PIN IS FRACTURED, THE HUMERAL BUSHINGS RETURNED ARE DAMAGED AND A DIMENSIONAL EVAL WAS NOT PERFORMED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON SAW ON X-RAY THAT THE INNER PART ON THE BUSHING HAD BACKED OUT. DURING REVISION SURGERY, IT WAS DISCOVERED THAT THE BUSHING HAD BROKEN IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW HUMERAL ASSEMBLY JDC ZIMMER, INC. 61413368

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention