BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER LEFT KNEE IMPLANT

    MDR report key: 2161208 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01031
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THREE TO FOUR YEARS AFTER KNEE REPLACEMENT SURGERY THE PATIENT'S KNEE HAS BEGUN BUCKLING OR GIVING OUT ON HER. THE PATIENT RESEARCHED ON THE INTERNET AND FOUND THAT HER IMPLANTS MAY HAVE BEEN RECALLED. THEY WOULD LIKE TO KNOW IF HER IMPLANT HAS BEEN RECALLED. HER PRIMARY SURGEON IS NO LONGER IN PRACTICE. SHE IS NOW SEEING DR (B)(6)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other