BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P NON-BEADED

    MDR report key: 2234049 · Received August 29, 2011

    Report

    Report Number
    2249697-2011-01265
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K920034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REVISED AN OLD DURACON TS BASEPLATE THAT HAS COME DISASSOCIATED FROM 155MM PRESSFIT STEM. BONE OF PROXIMAL TIBIA HAD RESORBED FROM UNDER TIBIAL BASEPLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON UNIVERSAL B/P NON-BEADED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA YLMU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention