BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET

    MDR report key: 20616861 · Received November 6, 2024

    Report

    Report Number
    1038671-2024-04252
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862186751
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): A429693 308-01-08 - 8X80MM DISTAL STEM MODULAR CEMENTED, A335126 308-05-19 - DISTAL FIXATION RING HA 19.5, B032561 308-10-00 - MED PROX BODY +0, A325338 308-10-50 - 50MM MIDDLE SEGMENT MODULAR, B124301 308-10-75 - 75MM MIDDLE SEGMENT MODULAR, 7092779 308-16-25 - TAPER LOCKING SCREW 125, B047306 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, B118905 320-15-01 - EQ REV GLENOID PLATE, B020949 320-15-05 - EQ REV LOCKING SCREW, B077425 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, S532378 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM, B080187 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, B019474 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, S525734 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM, A464891 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT, A920763 321-52-09 - 3.2MM K-WIRE, TROCAR TIP.

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-04253 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 H10 THE FOLLOWING SECTIONS WERE CORRECTED: B2 G4:510K H6 THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE AS STATED IN THE EXPERIENCE REPORT. OTHER CONTRIBUTING FACTORS MAY BE PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY ONE MONTHS POST OPERATION. HRP WAS DISLOCATING DUE TO LACK OF SOFT TISSUE TENSION. PATIENT REVISED TO EXACTECH DEVICES: LINER AND GLENOSPHERE WERE UPSIZED TO 42MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405429 RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862186751

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| H