BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21246509 · Received January 27, 2025

    Report

    Report Number
    1038671-2025-00457
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    December 27, 2024
    Report Date
    May 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. D1: CORRECTED, D4: CORRECTED, H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES. H10 RELATED REPORT NUMBERS: 1038671-2025-00453 & 1038671-2025-00450.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-30-06 - EQUINOXE PRESERVE STEM 6MM: 6741415 (IMPLANTED 02-02-2021 - NOT REVISED); 320-15-01 - EQ REV GLENOID PLATE: 6761305 (IMPLANTED 02-02-2021 - NOT REVISED); 320-42-00 - 145-DEG PE 42MM HUM LINER +0: S221548; 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6789290; 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 6574463. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    APPROXIMATELY 3 YEAR(S), 8 MONTH(S) AND 4 DAY(S) POST-OPERATIVE OF A REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ANOTHER DISLOCATION. IT WAS REPORTED THAT PATIENT WAS HANGING DRYWALL AND FELT SHOULDER DISLOCATE. A PRIOR REVISION TOOK PLACE DUE TO DISLOCATION WITH DISSOCIATION OF POLYETHYLENE. THE PATIENT UNDERWENT A CLOSED REDUCTION IN CLINIC FOR THE SECOND DISLOCATION; AND WAS PRESCRIBED SLING USE, RELATIVE REST, GRADUAL RETURN TO ACTIVITY. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772151 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H11.