BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOSPHERE 38MM

    MDR report key: 16293307 · Received February 3, 2023

    Report

    Report Number
    1038671-2023-00099
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 13, 2023
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862563699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE DISLOCATION AND SUBSEQUENT CLOSED REDUCTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RECONSTRUCTION.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. A193237 300-30-08 - EQUINOXE PRESERVE STEM 8MM. A300104 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A163919 320-15-05 - EQ REV LOCKING SCREW. 6913850 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE. A232101 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S393828 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 6154853 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. A174174 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S384740 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. A254659 320-38-03 - 145-DEG PE 38MM HUM LINER +2.5. A287283 321-52-07 - 3.2MM DRILL BIT STERILE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. 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, 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

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2022. THE STEM, POLY AND TRAY WERE REVISED ON (B)(6) 2023 DUE TO TOTAL SHOULDER DISLOCATION. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175521 GLENOSPHERE 38MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 320-06-38 10885862563699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.