BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ROTATING HINGE KNEE

    MDR report key: 2384774 · Received November 18, 2011

    Report

    Report Number
    1822565-2011-02557
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    September 21, 2011
    Report Date
    October 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A HINGE POST EXTENSION, SIZE 17 WAS RETURNED WITH THE COMPLAINT FOR REVIEW. VISUAL EXAMINATION REVEALS THAT THE DEVICE IS IN GOOD CONDITION. THREAD GAUGES, MICROMETERS, AND CALIPERS WERE USED TO PERFORM DIMENSIONAL ANALYSIS. DIMENSIONAL ANALYSIS REVEALED THAT THE DEVICE IS CONFORMING TO PRINT SPECIFICATION. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR THE 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 THE SURGEON WAS UNABLE TO TIGHTEN DOWN THE HINGE PIN SO HE IMPLANTED ANOTHER HINGE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ROTATING HINGE KNEE KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1