BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER FEMORAL COMPONENT

    MDR report key: 1780336 · Received July 26, 2010

    Report

    Report Number
    2249697-2010-00902
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICES CANNOT BE PERFORMED AS THEY WERE INADVERTENTLY DISPOSED OFF BY PATHOLOGY AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER. THE CATALOG NUMBER AND LOT CODE FOR THE REPORTED DEVICES WERE NOT PROVIDED. ADDITIONAL INFORMATION PERTAINING TO THE DEVICES REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2010-00903.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "RIGHT KNEE ASEPTIC LOOSENING. REVISION RIGHT TOTAL KNEE ARTHROPLASTY ALL COMPONENTS." ADDITIONAL INFORMATION RECEIVED 7/22/2010: "FAILED FEMORAL COMPONENT" AND "FAILED TIBIAL COMPONENT". THE EXACT IMPLANTATION DATE WAS NOT PROVIDED, HOWEVER, IT WAS INDICATED THAT THE REPORTED DEVICES WERE IMPLANTED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRYKER FEMORAL COMPONENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention