BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P NON-BEADED

    MDR report key: 1622692 · Received March 2, 2010

    Report

    Report Number
    2249697-2010-00248
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K920034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSP POLICY. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ROUTINE REVISION OF TKA DONE ELSEWHERE (B) (6).2000. FEMORAL COMPONENT WAS FOUND BY DR K TO BE WELL FIXED AND WELL ALIGNED. DR K FOUND THE TIBIAL COMPONENT TO BE MALROTATED. TIBIAL COMPONENT WAS REMOVED AND REPLACED WITH A NEW DURACON UNIVERSAL TIBIAL BASEPLATE WITH IMPROVED ROTATIONAL ORIENTATION AND A NEW PS INSERT COMPATIBLE WITH THE DURACON PS FEMORAL COMPONENT. CATALOG NUMBERS OF THE IMPLANTS FROM (B) (6).2000 WERE NOT AVAILABLE; HOWEVER, THE OPERATIVE REPORT INDICATED, IT TO BE A MEDIUM DURACON PS FEMORAL COMPONENT. THE ABOVE CATALOG # OF THE BASEPLATE WAS READ OFF THE IMPLANT UPON REMOVAL. THERE WAS NO NUMBER TO READ OFF THE INSERT, JUST THE LOT. HOSP POLICY PROHIBITS TAKING THESE COMPONENTS AFTER EXPLANTATION."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention