BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE-READY CABLE GRIP SYSTEM

    MDR report key: 3032535 · Received March 29, 2013

    Report

    Report Number
    1822565-2013-00562
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO X-RAYS OR PRODUCT WERE RETURNED FOR INSPECTION. THERE IS NOT ENOUGH INFO TO DETERMINE THE CAUSE OF THE PAIN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, 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 THE PT IS EXPERIENCING PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130212 CABLE-READY CABLE GRIP SYSTEM TRAUMA PROSTHESIS JDQ ZIMMER, INC. 60398607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other