BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

    MDR report key: 15372730 · Received September 7, 2022

    Report

    Report Number
    1038671-2022-01047
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 18, 2022
    Report Date
    January 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-05-01, +5 STD LEFT TRAY, 6864690. 320-05-11, +5 LAT LEFT TRAY, 6847791. 320-15-05, EQ REV LOCKING SCREW, A017251. 320-20-00, EQ REVERSE TORQUE DEFINING SCREW KIT, A070327. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, S369770, S369783, S369789, S369790. 320-20-42, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM, 5727275. 320-32-36, EXPANDED GLENOSPHERE, 36MM, FOR SMALL REVERSE, 7007188. 320-35-02, SMALL SUPERIOR AUGMENT GLENOID PLATE, 7318317. 320-36-00, 36MM HUMERAL LINER +0 UNCONSTRAINED, 7214120. 321-52-07, 3.2MM DRILL BIT STERILE, 6603454. 321-52-09, 3.2MM K-WIRE, TROCAR TIP, A010585. 521-78-32, THREADED PIN SIZE 3.0 COLLARLESS 2PK, S337812. 531-78-20, SHOULDR GPS HEX PINS KIT, A044934. A10012, GPS IMPLANT KIT V2, 04008621298.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITIONS AND NOTED POOR HEALTH. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, THIS FEMALE PATIENT HAD AN INDEX REVERSE SHOULDER ON HER LEFT SIDE WAS 7/18/22 DUE TO SEVERAL INJUSTICES INCLUDING PROXIMAL HUMERUS FRACTURE. PATIENT HAD WOUND COMPLICATIONS WITH THE INCISION NOT HEALING AFTER SURGERY POSSIBLY RELATED TO POOR PROTOPLASM PER SURGEON. SURGEON REMOVED THE IMPLANTS AND CEMENTED IN A ANTIBIOTIC SHOULDER SPACER AFTER I&D. THERE WERE NO REPORTED ISSUES DURING SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMPLANTS NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FILMS AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, THIS FEMALE PATIENT HAD AN INDEX REVERSE SHOULDER ON HER LEFT SIDE WAS (B)(6) 2022 DUE TO SEVERAL INJUSTICES INCLUDING PROXIMAL HUMERUS FRACTURE. . PATIENT HAD WOUND COMPLICATIONS WITH THE INCISION NOT HEALING AFTER SURGERY POSSIBLY RELATED TO POOR PROTOPLASM PER SURGEON. SURGEON REMOVED THE IMPLANTS AND CEMENTED IN A ANTIBIOTIC SHOULDER SPACER AFTER I&D. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMPLANTS NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FILMS OR FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, THIS FEMALE PATIENT HAD AN INDEX REVERSE SHOULDER ON HER LEFT SIDE WAS 7/18/22 DUE TO SEVERAL INJUSTICES INCLUDING PROXIMAL HUMERUS FRACTURE. PATIENT HAD WOUND COMPLICATIONS WITH THE INCISION NOT HEALING AFTER SURGERY POSSIBLY RELATED TO POOR PROTOPLASM PER SURGEON. SURGEON REMOVED THE IMPLANTS AND CEMENTED IN A ANTIBIOTIC SHOULDER SPACER AFTER I&D. THERE WERE NO REPORTED ISSUES DURING SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. IMPLANTS NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FILMS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2683955 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 300-01-11 UNK 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention