BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MIS TIBIAL TRAY

    MDR report key: 1915684 · Received December 1, 2010

    Report

    Report Number
    1822565-2010-01253
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    January 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SURGICAL NOTES OR X-RAYS WERE PROVIDED TO UNDERSTAND THE FIXATION. WITH THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR PATIENT'S PAIN AND REVISION CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention