BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STM PROTECTOR

    MDR report key: 24501135 · Received March 3, 2026

    Report

    Report Number
    1038671-2026-00221
    Event Type
    Injury
    Date Received
    March 3, 2026
    Report Date
    March 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862079718
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-60-02 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 2: B262600. 310-62-44 - STEMLESS HUMERAL HEAD 44MM X 14MM X BETA: A991142. 314-24-33 - LASER CAGE GLENOID M, 8 POST AUG, RIGHT: B337447. 315-35-00 - GLND KWIRE: B441939. 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM: B363437. 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK: B363821. 531-78-20 - SHOULDR GPS HEX PINS KIT: B132145. A10012 - GPS IMPLANT KIT V2: 09008824150. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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

    THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY. FOLLOWING THE PROCEDURE, IT WAS DISCOVERED THAT A HUMERAL CUT PROTECTION PLATE HAD BEEN INADVERTENTLY RETAINED WITHIN THE SURGICAL SITE. THE RETAINED OBJECT CAUSED A LACERATION OF THE SUBSCAPULARIS TENDON. AS A RESULT, THE PATIENT REQUIRED A SUBSEQUENT SURGICAL PROCEDURE FOR REMOVAL OF THE RETAINED FOREIGN BODY AND REPAIR OF THE INJURED TENDON. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484429 STM PROTECTOR PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862079718

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Hospitalization SEE H11.