BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

    MDR report key: 19260490 · Received May 7, 2024

    Report

    Report Number
    1038671-2024-01089
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862242563
    PMA / PMN Number
    K131575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: CONCOMITANT PRODUCTS 6612419 - 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 6589796 - 320-01-36 - 36MM GLENOSPHERE 6677928 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6628461 - 320-15-05 - EQ REV LOCKING SCREW 6552988 - 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE 6642518 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S064650 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S092961 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S066037 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S082295 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S099376 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S113258 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 6635106 - 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED 6616804 - 531-20-00 - SHLDR GPS RVRS DRILL KIT 6616993 - 531-78-20 - SHOULDR GPS HEX PINS KIT 6706271 - 531-78-20 - SHOULDR GPS HEX PINS KIT 3009120095 - A10012 - GP ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4 MODEL NUMBER. THE SCAPULAR FRACTURE REPORTED IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND BONE QUALITY. THE FRACTURE OF THE INFERIOR COMPRESSION SCREW IS MOST LIKELY SECONDARY TO THE SCAPULAR FRACTURE AND SUBSEQUENT SUBJECTION OF THE COMPRESSION SCREW TO HIGH LOADS RESULTING IN THE MATERIAL FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR PHOTOS WERE 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

    REPORT NUMBER: 1038671-2024-02580 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8. G1. THE FOLLOWING SECTIONS WERE CORRECTED: B2. D1. D4. G4: 510K CORRECTED. H4. H6. THE SCAPULAR FRACTURE REPORTED IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND BONE QUALITY. THE FRACTURE OF THE INFERIOR COMPRESSION SCREW IS MOST LIKELY SECONDARY TO THE SCAPULAR FRACTURE AND SUBSEQUENT SUBJECTION OF THE COMPRESSION SCREW TO HIGH LOADS RESULTING IN THE MATERIAL FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR PHOTOS WERE 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

    H3: THE SCAPULAR FRACTURE REPORTED IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND BONE QUALITY. THE FRACTURE OF THE INFERIOR COMPRESSION SCREW IS MOST LIKELY SECONDARY TO THE SCAPULAR FRACTURE AND SUBSEQUENT SUBJECTION OF THE COMPRESSION SCREW TO HIGH LOADS RESULTING IN THE MATERIAL FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO RADIOGRAPHS OR PHOTOS WERE PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED, THE 74 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024. THE PATIENT EXPERIENCED A SCAPULA FRACTURE AND THE BASEPLATE AND GLENOSPHERE SPUN 180 DEGREES AND WAS UPSIDE DOWN. THE INFERIOR SCREW HAD BROKEN. THERE WAS METALOSIS AS A RESULT OF THE IMPLANT ARTICULATING AT AN ACUTE ANGLE. THE STEM WAS STILL WELL FIXED AND THERE WAS NO PRESENCE OF INFECTION. THE PATIENT IS A RHEUMATOID ARTHRITIS SUFFERER AND THERE WAS SIGNIFICANT RESORBTION OF THE TUBEROSITIES. ALL IMPLANTS WERE REMOVED EXCEPT THE STEM. A NEW ANATOMIC REPLICA PLATE, SCREW AND A CTA HEAD WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT HAS A HEMI ARTHROPLASTY NOW AND SHOULD BE COMFORTABLE. PATIENT RANGE OF MOTION (ROM) AND FUNCTION WILL BE VERY LIMITED HOWEVER. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS WERE SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440586 SUP/POST AUG PLATE, R RS GLENOID BASEPLATE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE UNK 10885862242563

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Hospitalization| R