BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18481214 · Received January 9, 2024

    Report

    Report Number
    1038671-2024-00062
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    June 14, 2022
    Report Date
    July 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862515766
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0: 5379926. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5675956. 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 5680089. 320-15-01 - EQ REV GLENOID PLATE: 5617118.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. D1: CORRECTED D4/D6: DEVICE, SERIAL #, UDI #, EXPIRATION, IMPLANT AND EXPLANT DATES UNKNOWN. G3: MANUFACTURED DATES UNKNOWN. G4: PMA 510K CANNOT BE DETERMINED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    STUDY: EQUINOXE SHOULDER STUDY. SUBJECT: (B)(6). AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2018 AND PRESENTED ON AND UNKNOWN DATE IN 2021 WITH PAIN - UNEXPLAINED; SUPERIOR SHOULDER PAIN WITHOUT EVIDENCE OF FRACTURE. INCREASED PAIN WITHOUT INJURY DURING THE SUMMER OF 2021. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. PATIENT ADVISED TO TAKE ACTION OF IMMOBILIZATION FOR 6 WEEKS. THE OUTCOME OF THIS EVENT IS RESOLVED ON 14-JUN-2022. HEIGHT: 63 IN / BMI: 26. PREVIOUS SURGERY ON INVOLVED SHOULDER? YES, ON (B)(6) 2008; ROTATOR CUFF REPAIR. DIAGNOSIS: ROTATOR CUFF TEAR. OTHER DIAGNOSIS: FUNCTIONAL PSEUDOPARALYSIS. COMORBIDITIES: HYPOTHYROIDISM. 300-30-08 - EQUINOXE PRESERVE STEM 8MM: 5569575. 510K: K162726. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682901 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862515766

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female SEE H10.