BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 18052467 · Received November 1, 2023

    Report

    Report Number
    1038671-2023-02655
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    October 10, 2023
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING EVALUATION. D10: 7300745 -304-22-13 - 12.5MM PLATFORM FX STEM RIGHT. A286626 320-00-02 - 0 STD RIGHT TRAY. 6805878 320-15-01 - EQ REV GLENOID PLATE. A602327 320-15-05 - EQ REV LOCKING SCREW. A710520 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A462849 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. A192054 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. A682797 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S420335 320-42-00 - 145-DEG PE 42MM HUM LINER +0. S480090 320-42-00 - 145-DEG PE 42MM HUM LINER +0. 6090568 320-42-03 - 145-DEG PE 42MM HUM LINER +2.5. A345075 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE. A720246 531-78-20 - SHOULDR GPS HEX PINS KIT. 5014923098 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE INTRAOPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION OR HIGH FORCES DURING BROACHING, REAMING, EXPOSURE, OR RETRACTION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION 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, THE PATIENT PRESENTED TO THE SURGEON WITH A PROXIMAL HUMERAL FRACTURE. THE SURGEON PERFORMED A REVERSE TSA USING A HUMERAL FRACTURE STEM AND HAT IMPLANT ALONG WITH EXACTECH GLENOID/GLENOSPHERE ON (B)(6) 2023. DURING THE FINAL IMPLANT REDUCTION, THE SURGEON FELT THAT THE REAL IMPLANT COMPONENTS DID NOT MATCH HOW THE TRIAL COMPONENTS FELT. HE EXAMINED THE SHOULDER AND DECIDED TO GO UP IN POLY THICKNESS FROM +0MM TO A +2.5MM. AFTER INCREASING THE POLY THICKNESS THE SHOULDER ANTERIORLY STILL FELT LOOSE TO WHICH THE SURGEON DISCOVERED A CORACOID FRACTURE HAD HAPPENED. THE GLENOID WAS NAVIGATED USING GPS AND A CORACOID BLOCK WITH TWO SCREWS WAS PLACED DURING THE PROCEDURE. THE SURGEON IS UNSURE THE CAUSE OF THE CORACOID FRACTURE, THOUGH PROCEEDED TO FIX THE FRACTURE USING A 4.0MM CANNULATED SCREW WITH A WASHER. THE SURGEON FELT THE SHOULDER WOULD BE TIGHTER AFTER FIXING THE CORACOID SO WENT BACK DOWN IN POLY THICKNESS TO A +0MM. THE PATIENT WILL BE LIMITED IN MOTION DURING POST-OP THERAPY TO TRY TO HELP INCREASE HEALING OF THE CORACOID FRACTURE. THE PROCEDURE TOOK LONGER THAN EXPECTED (15-30 MINUTES) DUE TO THE CORACOID FRACTURE AND ADDING THE PROCEDURE TO FIX THE FRACTURE. MULTIPLE TRIALING WAS NEEDED AS WELL. THERE WAS NO ADVERSE EVENT AS A RESULT OF THE PROLONGATION. THE PATIENT LEFT THE OR STABLE. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157825 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention