BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ELBOW

    MDR report key: 2041229 · Received March 30, 2011

    Report

    Report Number
    1822565-2011-00796
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    October 6, 2010
    Report Date
    March 3, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED. IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. FAILURE MAY HAVE BEEN INITIATED BY THE FALL. CAUSE OF FAILURE CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER EXPERIENCING A FALL, THE PT EXPERIENCED PAIN. AN X-RAY REVEALED THAT THE HINGE HAD UNCOUPLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER ELBOW ELBOW PROSTHESIS JDB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention