BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM HUMERAL LINER +0 UNCONSTRAINED

    MDR report key: 18334731 · Received December 15, 2023

    Report

    Report Number
    1038671-2023-02994
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 29, 2023
    Report Date
    April 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K093275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 5672297 - 300-30-14 - EQUINOXE PRESERVE STEM 14MM 6487699 -315-35-00 - GLND KWIRE 6537562 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6537145 - 320-15-05 - EQ REV LOCKING SCREW 6575030 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6302974 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S080215 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 5891478 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S086710 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 6464276 - 320-31-36 - GLENOSPHERE, 36MM 6440092 - 320-35-04 - SMALL POSTERIOR AUGMENT GLENOID PLATE, RIGHT 6466966 - 320-36-00 - 145-DEG PE 36MM HUM LINER +0 6520536 - 531-20-00 - SHLDR GPS RVRS DRILL KIT 6617433 - 531-78-20 - SHOULDR GPS HEX PINS KIT 2025520308 - A10012 - GPS IMPLANT KIT V2 2039220041 - A10012 - GPS IMPLANT KIT V2

    Additional Manufacturer Narrative · 0

    USER-RELATED CONSIDERATIONS: THERE WERE NO USER-RELATED ISSUES REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT-RELATED CONSIDERATIONS: THERE ARE NO PATIENT CONDITIONS REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REASON FOR THE REVISION REPORTED CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION BUT MAY HAVE BEEN REPORTED AT THIS LATER TIME DUE TO INCLUSION OF ONE OF THE IMPLANTED DEVICES IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR AND INSTABILITY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS NO IMAGES OR RADIOGRAPHS WERE PROVIDED, RELEVANT CLINICAL INFORMATION WAS NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 CLINICAL CODE, PROBLEM CODE, AND COMPONENT CODE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. 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 TSA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR, WHICH CAUSED INSTABILITY. 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. THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885954 36MM HUMERAL LINER +0 UNCONSTRAINED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention SEE H10