BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19740095 · Received July 15, 2024

    Report

    Report Number
    1038671-2024-02386
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A939246, 320-31-40 - GLENOSPHERE, 40MM; A913580, 320-40-00 - 145-DEG PE 40MM HUM LINER +0; A857694, 300-30-10 - EQUINOXE PRESERVE STEM 10MM; A984692, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; A860084, 320-15-05 - EQ REV LOCKING SCREW; A921149, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; S528866, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; A918975, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; S533910, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; S282094, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; A903774, 320-35-08 - SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE, RIGHT; 01014024161, A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    D1: CORRECTED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 1 MONTH AFTER INITIAL RTSA, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT DURING HIS POST-OPERATIVE RECOVERY PERIOD DID NOT FOLLOW THE RANGE OF MOTION CONSTRAINTS AND ATTEMPTED TO REACH INTO THE BACK SEAT OF A CAR WHILE SITTING IN THE FROM SEAT TO GRAB AN ITEM, DISLOCATING HIS SHOULDER. THE SHOULDER COULD NOT BE CLOSED REDUCED. THE SURGEON PUT IN A NEW GLENOSPHERE, STEM, TRAY AND LINER. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285943 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11