BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20112695 · Received August 30, 2024

    Report

    Report Number
    1038671-2024-03206
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    February 21, 2018
    Report Date
    December 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE CAUSE OF THE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A COMBINATION OF FORCES APPLIED DURING THE SURGICAL PROCEDURE OR PATIENT-RELATED RISK FACTORS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. 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

    CONCOMITANT DEVICE(S): 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 5213416. 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0: 5184043. 306-02-08 - EQUINOXE, HUMERAL LONG STEM 8MM 215MM: 3948882. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5211678. 320-15-01 - EQ REV GLENOID PLATE: 5120739. 320-15-05 - EQ REV LOCKING SCREW: 5197338. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5219576. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 5171209. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5217416. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5217448. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 4994425. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: 4315956.

    Description of Event or Problem · 0

    INTRA-OPERATIVELY OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED HUMERAL FRACTURE. HUMERAL SPIROID SHAFT FRACTURE DURING GLENOID EXPOSITION. DURING THE INITIAL IMPLANTATION THERE WAS OSTESYNTHESIS OF HUMERAL SHAFT AND CEMENTED LONG STEM. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND ADDITIONAL COMMENTS WERE "HUMERAL FRACTURE ALMOST HEALING". THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804240 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| R SEE H11.