BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21048056 · Received December 31, 2024

    Report

    Report Number
    1038671-2024-05103
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    August 29, 2018
    Report Date
    May 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION AND/OR SUBLUXATION ARE KNOWN RISKS, AS OUTLINED IN THE IFU. B3: CORRECTED. D1: CORRECTED. H6: CORRECTED INVESTIGATION CLINICAL CODES. H10 RELATED REPORT NUMBERS: 1038671-2024-05063 & 1038671-2024-05064.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 4742879, 320-46-00 - EQUINOXE REVERSE 46MM HUMERAL LINER +0: 4672406, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 4822082, 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: 4811542, 320-15-01 - EQ REV GLENOID PLATE: 4804483. 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 1 YEAR(S), 4 MONTH(S) AND 4 DAY(S) POST-OPERATIVE OF AN INITIAL LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF OTHER COMPONENT - DISLOCATION OF MODULAR DEVICE DURING PHYSICAL ACTIVITY. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116342 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization SEE H11.