BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 14961263 · Received July 8, 2022

    Report

    Report Number
    3006742481-2022-00005
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 8, 2022
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    PMA / PMN Number
    K172688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT EXPERIENCED COMPLIACATIONS WITH A RADIAL HEAD PROSTHESIS THAT WAS IMPLANTED IN 2014. THE PATIENT REGULARLY PLAYED TENNIS AND IT APPEARS THIS MAY HAVE CONTRIBUTED TO THIS FAILURE. THE IFU FOR THIS IMPLANT STATES " THE PATIENT MUST BE CAUTIONED, PREFERABLY IN WRITING, ABOUT THE USE, LIMITATIONS AND POSSIBLE ADVERSE EFFECTS OF THIS DEVICE INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT OF STRESS, EXCESSIVE ACTIVITY, WEIGHT BEARING, OR LOAD BEARING." THIS INDICATES THAT THE IMPLANT MOST LIKELY FAILED DUE TO STRENUOUS ACTIVITY OVER A LONG PERIOD OF TIME.

    Description of Event or Problem · 0

    A 59 YEAR OLD FEMALE PATIENT REPORTED PAIN IN HER ELBOW. X-RAYS REVEALED THE ALIGN RADIAL HEAD PROSTHESEIS SHEARED AT THE NECK OF THE IMPLANT.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503550 SKELETAL DYNAMICS ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN0913033

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention