BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL SUPERIOR AUGMENT GLENOID PLATE

    MDR report key: 18763374 · Received February 22, 2024

    Report

    Report Number
    1038671-2024-00307
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    May 31, 2024
    Report Date
    April 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862534873
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS A2, B5, D1, D2A, D2B, D4, D6B, D10, H1 AND H6 HAVE BEEN UPDATED ACCORDINGLY. CONCOMITANT DEVICES: 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: (B)(6). 320-32-40 - EXPANDED GLENOSPHERE, 40MM, FOR SMALL REVERSE: (B)(6). 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: (B)(6). 315-35-00 - GLND KWIRE: (B)(6). 320-15-05 - EQ REV LOCKING SCREW: (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: (B)(6). 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: (B)(6). 320-40-03 - HUMERAL LINER, 40MM, +2.5: (B)(6).

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 6168975. 315-35-00 - GLND KWIRE: 5903106. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6186576. 320-15-05 - EQ REV LOCKING SCREW: 6209183. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6224106. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 6225730. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 6080509. 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE: 5955433. 320-40-03 - HUMERAL LINER, 40MM, +2.5: 5813540.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1/D2A/D2B, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF ASEPTIC GLENOID LOOSENING. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS COULD NOT BE ASSESSED AS THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WERE PROVIDED. 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 BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEARS, 2 MONTHS, AND 15 DAYS POST-OPERATIVELY OF AN INITIAL RTSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. X-RAY SHOWS RTSA BASEPLATE FAILURE WITHOUT INCREASE IN PAIN OR TRAUMA; SUBJECT WAS LAST SEEN IN 2021. THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 69-YEAR-OLD MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6)2019 AND PRESENTED WITH ASEPTIC GLENOID LOOSENING ON (B)(6)2024. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND WITH NO ACTION TAKEN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112969 SMALL SUPERIOR AUGMENT GLENOID PLATE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862534873
    230886 SMALL SUPERIOR AUGMENT GLENOID PLATE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862534873

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male SEE H10| SEE H11