BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ONE BIPOLAR

    MDR report key: 2964607 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00708
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING RECURRENT DISLOCATIONS INVOLVING A SYSTEM ONE BIPOLAR AND UNKNOWN HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER EVENTS HAVE BEEN REPORTED FOR THE MANUFACTURING LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BHA ON (B)(6) 2012 AND THE PATIENT HAD DISLOCATION MANY TIME AFTER THE BHA. (B)(6) 2013, THE PATIENT HAD DISLOCATION AGAIN SO THE SURGEON TRIED TO DO CLOSED REDUCTION WITH TRACTION. DURING THE PROCEDURE, THE SYSTEM ONE CAME OFF FROM THE INNER HEAD. FOR A REVISION SURGERY, THE PATIENT WILL TRANSFER TO ANOTHER HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BHA ON (B)(6) 2012 AND THE PATIENT HAD DISLOCATION MANY TIME AFTER THE BHA. (B)(6) 2013, THE PATIENT HAD DISLOCATION AGAIN SO THE SURGEON TRIED TO DO CLOSED REDUCTION WITH TRACTION. DURING THE PROCEDURE, THE SYSTEM ONE CAME OFF FROM THE INNER HEAD. FOR A REVISION SURGERY, THE PATIENT WILL TRANSFER TO ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66476 SYSTEM ONE BIPOLAR IMPLANT LXH STRYKER ORTHOPAEDICS-MAHWAH MLA77H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention