BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5MM PLATFORM FX STEM RIGHT

    MDR report key: 16758732 · Received April 17, 2023

    Report

    Report Number
    1038671-2023-00714
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    March 16, 2023
    Report Date
    July 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862083395
    PMA / PMN Number
    K092900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. 306-02-08 EQUINOXE HUMERAL LONG STEM 8MM 215MM 3672963, 320-10-05 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 6895242, 320-15-05 EQ REV LOCKING SCREW A110277, 320-20-00 EQ REVERSE TORQUE DEFINING SCREW KIT A230272, 320-20-26 EQ REV COMPRESS SCREW LCK CAP KIT 4.5 X 26MM S407385, 320-20-26 EQ REV COMPRESS SCREW LCK CAP KIT 4.5 X 26MM S407384, 320-20-26 EQ REV COMPRESS SCREW LCK CAP KIT 4.5 X 26MM A209772, 320-20-42 EQ REV COMPRESS SCREW LCK CAP KIT 4.5 X A183542, 320-32-36 EXPANDED GLENOSPHERE 36MM FOR SMALL REVERSE 7007266, 320-36-00 36MM HUMERAL LINER +0 UNCONSTRAINED A076781.

    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 INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    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: A, B, C, D, E, 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 RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED TO A REVERSE SHOULDER ON (B)(6) 2023 DUE TO SHOULDER INSTABILITY. DURING FINAL REDUCTION OF REVERSE IMPLANTS, THE GLENOID CONSTRUCT FIXATION FAILED DUE TO POOR BONE QUALITY. THE REVERSE COMPONENTS WERE THEN REMOVED AND REPLACED WITH ANATOMIC HEMI COMPONENTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210514 8.5MM PLATFORM FX STEM RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 304-22-09 10885862083395

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention SEE H10