BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC,

    MDR report key: 22947521 · Received September 2, 2025

    Report

    Report Number
    3006742481-2025-00007
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 2, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100050
    PMA / PMN Number
    K172688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM STATES THE FOLLOWING: "RADIAL HEAD PROSTHESIS CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. FAILURE OF THE COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION OR EXCESSIVE LOADS (ESTIMATED BODY WEIGHT EQUIVALENT OF 350 LBS OR GREATER)." "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 RESULT OF LOOSE FIXATION AND/OR LOOSENING, STRESS, EXCESSIVE ACTIVITY, OR WEIGHT BEARING OR LOAD BEARING, AND THE POSSIBILITY OF NERVE OR SOFT TISSUE DAMAGE RELATED TO EITHER SURGICAL TRAUMA OR THE PRESENCE OF THE DEVICE." "SEEK MEDICAL HELP IMMEDIATELY IF IMPLANT MALFUNCTIONS." THE RADIAL HEAD PROSTHESIS WAS ABLE TO FUNCTION NORMALLY IN THE PATIENT FOR AT LEAST TWO YEARS PRIOR TO THE TRAUMATIC EVENT WHICH OCCURRED IN 2020. THE AT THAT TIME SURGEON DID NOT OBSERVE ANY ISSUES WITH THE IMPLANTED RADIAL HEAD CONSTRUCT AND THE PATIENT, A VERY ACTIVE CARPENTER AND SPORTS PLAYER, ONLY REPORTED AN ISSUE WITH THEIR ELBOW IN 2025 AFTER PLAYING TENNIS. HOWEVER, THE EXTENT OF METAL DEBRIS AND WEAR TO THE RADIAL STEM FOUND DURING REMOVAL CLEARLY INDICATE THAT THE CONSTRUCT HAD FAILED MUCH EARLIER, POTENTIALLY EVEN AS A RESULT OF THE INCIDENT IN 2020.

    Description of Event or Problem · 0

    AN ALIGN RADIAL HEAD WHICH HAD BEEN IMPLANTED FOR OVER SEVEN YEARS WAS REMOVED DUE TO MOVEMENT OF THE RADIAL HEAD AROUND THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412358 SKELETAL DYNAMICS INC, ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN1608004 00841506100050

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention