BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20334560 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03745
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    February 8, 2024
    Report Date
    July 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: (B)(6) - 300-01-14 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM; (B)(6) - 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; (B)(6) - 300-50-45 - 4.5MM SHORT REP PLATE; (B)(6) - 310-00-50 - EQUINOXE, HUMERAL HEAD, EXTRA SHORT, 50MM; (B)(6) - 314-13-34 - EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; (B)(6) - 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/D2A/D2B, D4, G4, H4, H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, 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 REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION . 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, APPROXIMATELY 6.5 YEARS POST INITIAL TSA, THE 63 Y/O MALE PATIENT HAD A REVISION DUE TO INFECTION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO USED AN INTERSPACE. CONCOMITANT DEVICES: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM (CAT# 300-01-14 / SERIAL# (B)(6)). EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT (CAT# 300-20-02 / SERIAL# (B)(6)). 4.5MM SHORT REP PLATE (CAT# 300-50-45 / SERIAL# (B)(6)). EQUINOXE, HUMERAL HEAD, EXTRA SHORT, 50MM (CAT# 310-00-50 / SERIAL# (B)(6)). EQUINOXE CAGE GLENOID L, POST AUG, RIGHT (CAT# 314-13-34 / SERIAL# (B)(6)). EBI INITIAL SURGERY ATTACHED. 510K: K042021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041302 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H11