BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3915279 · Received July 7, 2014

    Report

    Report Number
    0002249697-2014-02556
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 13, 2012
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER KNEE. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012, PATIENT HAD HER KNEE REPLACED WITH THE USE OF A STRYKER SHAPEMATCH CUTTING GUIDE. SUBSEQUENT TO HER KNEE REPLACEMENT, PLAINTIFF BEGAN EXPERIENCING SIGNIFICANT KNEE PAIN AND DISCOMFORT AND JOINT INSTABILITY AND LIMITED ON MOBILITY. DIAGNOSTIC TESTING HAS REVEALED THAT THE KNEE REPLACEMENT IS MISALIGNED AND NEEDS TO BE REPLACED BUT THE DAMAGE IS SO EXTENSIVE THAT EVEN THOUGH THE KNEE NEEDS TO BE REPLACED, IT IS IMPOSSIBLE TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394188 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other