BEUDAMED
    FDA Adverse Event Injury Summary report: N

    100MM STANDARD ULNA COMPONENT, LEFT

    MDR report key: 3844239 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02021
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K062845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN ULNA STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A SOLAR ULNA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULNA COMPONENT OF HIS SOLAR ELBOW IS LOOSENED. PER EMAIL FROM THE REP, THE ULNA STEM IS LOOSE, UPCOMING SURGERY IN (B)(6).

    Description of Event or Problem · 1

    UPDATE ON 05/22/14: THE ULNA STEM IS LOOSE AND THE PLAN IS TO REMOVE IT, CLEAN OUT THE CEMENT AND INSERT A LONGER STEM. SURGERY IS IN (B)(6) BUT NO DEFINITE DATE YET. UPDATE ON 7/11/14: THE LOOSE ULNA STEM WAS REMOVED AND A LONGER 120MM ULNA STEM WAS CEMENTED IN PLACE. BONE GRAFT WAS ALSO APPLIED AT THE PROXIMAL ULNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321890 100MM STANDARD ULNA COMPONENT, LEFT IMPLANT HSD STRYKER ORTHOPAEDICS-MAHWAH ER2W32576

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O