BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 38MM CONST HUM LINER +0

    MDR report key: 20614884 · Received November 5, 2024

    Report

    Report Number
    1038671-2024-04253
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862086679
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT NUMBER: 1038671-2024-04252. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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.

    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.

    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
    1428924 145-DEG PE 38MM CONST HUM LINER +0 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862086679

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R SEE H11