BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P NON-BEADED

    MDR report key: 3092172 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01511
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K9125512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING LOOSENING INVOLVING A DURACON UNIVERSAL B/P NON-BEADED WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, MEDICAL RECORDS, AND X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    PATIENT HAD PAINFUL DURACON PS KNEE. ONCE OPENED, THE FEMUR AND BASEPLATE WERE LOOSE AND THE SCREW HAD BACKED OUT OF THE POLY.

    Description of Event or Problem · 1

    PATIENT HAD PAINFUL DURACON PS KNEE. ONCE OPENED, THE FEMUR AND BASEPLATE WERE LOOSE AND THE SCREW HAD BACKED OUT OF THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194491 DURACON UNIVERSAL B/P NON-BEADED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH IEDP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention