BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNIER SIMPLICITI NUCLEUS SIZE 1

    MDR report key: 16118872 · Received January 8, 2023

    Report

    Report Number
    0001649390-2023-00001
    Event Type
    Injury
    Date Received
    January 8, 2023
    Date of Event
    December 12, 2022
    Report Date
    January 6, 2023
    Manufacturer
    TORNIER INC
    Product Code
    PKC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE CLEARED UNDER CATALOG NUMBER DWG401 510K # K143552. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE HAS BEEN DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A TOTAL SHOULDER REPLACEMENT. DURING SURGERY, SURGEON NOTED THAT A TENDONOUS TEAR OF THE JUNCTION OF THE SUPRASPINATUS AND SUBSCAPULARIS TENDONS EXISTED. SURGEON PERFORMED A REPAIR USING ANCHORS. POST-OP REHABILITATION PROCEEDED WITHOUT INCIDENT. HOWEVER, SEVERAL MONTHS FOLLOWING PRIMARY SURGERY, PATIENT COMPLAINED OF INCREASING PAIN, SWELLING AND INSTABILITY OF SHOULDER JOINT. SURGEON PERFORMED A SHOULDER ARTHROSCOPY, TO DISCOVER FULL THICKNESS TEARS OF BOTH OF THE AFORE MENTIONED TENDONS. DISCUSSED WITH THE PATIENT, WHERE A DECISION WAS MADE TO CONVERT THE SURGERY TO A REVERSE SHOULDER REPLACEMENT. DURING SURGERY TODAY, BOTH HUMERAL AND GLENOID COMPONENTS WERE REMOVED, AS PER THE RECOMMENDED SURGICAL TECHNIQUE. THE SURGEON HAS NO EXPLANATION AS TO WHY THE PATIENT'S ROTATOR CUFF TENDONS DETERIORATED IN SUCH A SHORT PERIOD OF TIME, RENDERING THE PROSTHETIC JOINT UNSTABLE, OTHER THAN HIS BELIEF THAT MICROSCOPIC POLY DEBRIS MAY HAVE SET UP AN INFLAMMATORY LOCAL RESPONSE THAT INHIBITED THE TENDON TEAR TO HEAL. ALL COMPONENTS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483883 TORNIER SIMPLICITI NUCLEUS SIZE 1 PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO PKC TORNIER INC CC0918256096

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention