BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT

    MDR report key: 15407634 · Received September 12, 2022

    Report

    Report Number
    1038671-2022-01092
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 23, 2022
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    UDI-DI
    10885862534880
    PMA / PMN Number
    K182536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM A000074, 315-35-00 - GLND KWIRE A057468, 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM 6824839, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A084489, 320-15-05 - EQ REV LOCKING SCREW A017754, A068745 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A062854, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 5915399, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 5718786, S364171 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S358398, S358400 320-31-36 - GLENOSPHERE, 36MM 7299547 320-35-03 - SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT 6597311, 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED A077294, 531-20-00 - SHLDR GPS RVRS DRILL KIT A003021, 531-78-20 - SHOULDR GPS HEX PINS KIT A044568, A10012 - GPS IMPLANT KIT V2 03008921021.

    Additional Manufacturer Narrative · 0

    H3: THE MISSING THREADS REPORTED WERE LIKELY DUE TO AN ERROR IN THE MANUFACTURING PROCESS, WHICH RESULTED IN THE BASEPLATE BEING MANUFACTURED WITHOUT CENTRAL HOLE THREADS.

    Description of Event or Problem · 0

    AS REPORTED, THE SURGEON IMPACTED THE GLENOID BASEPLATE AND PROCEEDED TO PUT IN HIS COMPRESSION SCREWS AND LOCKING CAPS. AFTER HIS LOCKING CAPS WERE TIGHTENED HE WENT TO PLACE THE SMALL 36 GLENOSPHERE OVER THE SMALL POSTERIOR 8 DEGREE BASEPLATE. ONCE THE GLENOSPHERE WAS SEATED ON THE BASEPLATE THE SURGEON PROCEEDED TO INSERT THE GLENOSPHERE LOCKING SCREW. THE SURGEON STATES THAT THE SCREW WOULD JUST TURN AND NOT ENGAGE INTO THE CAGE. WHEN THE SURGEON EXPLANTED THE ORIGINAL POSTERIOR 8 DEGREE AUGMENTED BASEPLATE, HE NOTICED THAT THERE WERE NO SCREW THREADS IN THE BASEPLATE ITSELF. HE IS CONFIDENT THAT HE DID NOT STRIP OUT THE THREAD, BECAUSE THERE WAS NO EVIDENCE OF METAL DEBRIS. THE SURGEON ASKED TO OPEN UP A NEW BASEPLATE AND LOCKING SCREW. THE THREADS WERE VISIBLE AND THE SECOND BASEPLATE AND LOCKING SCREW IMPLANTED AS EXPECTED. THERE WAS A 15-30 MINUTE DELAY DUE TO FIGURING OUT AN ALTERNATIVE METHOD OF REMOVING THE BASEPLATE. THE SURGEON WANTED TO BE ABLE TO REMOVE THE IMPLANT BY PULLING STRAIGHT OUT, COMPARED TO ADDING ANY TORSIONAL OR LEVERING FORCES. HE ULTIMATELY USED A BONE FORCEPS TO PULL THE IMPLANT OUT. THE PATIENT CONTINUED WITH SURGERY WITH NO KNOWN ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579793 SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT 10885862534880

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention SEE H10.