BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18861547 · Received March 7, 2024

    Report

    Report Number
    1038671-2024-00432
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 12, 2024
    Report Date
    June 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    UDI-DI
    10885862079329
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-10-10 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10: 5232147. 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 5645362. 320-15-05 - EQ REV LOCKING SCREW: 5600768. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5667604. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE STERILE CERTIFICATES AND THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. B3: CORRECTED. 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A LEFT TSA ON (B)(6) 2019 AND PRESENTED WITH DEEP INFECTION, ON (B)(6) 2022. PATIENT WAS SEEN ON (B)(6) 2022. DESCRIBES SIGNIFICANT PAIN SHOULDER WHILE ATTEMPTING TO LIFT A 50LBS. BAG 6 WEEKS PRIOR TO VISIT. WORK UP W/ CT INDICATED RCT. REVISION WAS RECOMMENDED TO CONVERT TO RTSA. PATIENT DELAYED SURGERY FOR OVER A YEAR. INTRA-OP FINDINGS SHOWED AN INTACT RC. SIGNIFICANT SYNOVITIS WAS ENCOUNTERED, AND A DEEP INFECTION WAS SUSPECTED. A STAGE REVISION WAS CARRIED OUT BY PLACING A SPACER. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2024. THE ACTION TAKEN WAS REVISION ON WITH THE REMOVAL OF THE STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, GLENOID. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170688 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H10