BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4233270 · Received November 6, 2014

    Report

    Report Number
    0002249697-2014-04204
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    March 27, 2006
    Report Date
    October 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN RIGHT KNEE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ALL COMMUNICATION RELATED TO THIS EVENT WILL BE HANDLED BY THE STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT HAD BEEN IN PAIN FOR PAST COUPLE OF YEARS AFTER HAVING HIS RIGHT KNEE IMPLANTED. PATIENT WAS REVISED TO COMPETITOR'S DEVICES ON (B)(6) 2014. HE IS LOOKING FOR COMPENSATION FOR HIS SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712649 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention