BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781203 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01648
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    May 23, 2012
    Report Date
    April 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN TRIATHLON KNEE SYSTEM. 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. DEVICE: NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT A KNEE REPLACEMENT IN WHICH A SHAPEMATCH CUTTING GUIDE WAS UTILIZED . AS A RESULT OF THE USE OF THE SHAPEMATCH THE PATIENT ALLEGEDLY SUSTAINED AN INJURY WHICH REQUIRED ADDITIONAL MEDICAL TREATMENT, INCLUDING A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260774 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention