BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19571076 · Received June 19, 2024

    Report

    Report Number
    1038671-2024-02021
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    July 25, 2019
    Report Date
    September 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 308-01-06 - 6X80MM DISTAL STEM MODULAR CEMENTED: 5683983. 320-31-36 - GLENOSPHERE, 36MM: 5836538. 320-35-01 - SMALL GLENOID PLATE: 5725119. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6045627. 320-15-05 - EQ REV LOCKING SCREW: 5960566. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5974369. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5945774. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 5778659. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 6014900. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5778945. 308-15-12 - TAPER LOCKING SCREW 12.5: 5689655. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 5979188 ASA0030 - STERILE DISPOSABLE CONTAINERS: AB3627 CNL-09 - SMALL CEMENT CANNULA: AB0898R CNL-09 - SMALL CEMENT CANNULA: AB3968 13A2101 - CEMEX SYSTEM FAST GENTA 70G: AB4106 13A2111 - CEMEX SYSTEM FAST GENTA 40G: AB0991 308-05-20 - DISTAL FIXATION RING HA 20.5: 5486439 308-09-12 - SMALL PROX BODY +12.5: 5989046

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1, D4, G3, G4, H3, H4, H6, H11. PLEASE DISREGARD THE DATES IN D4 (EXPIRATION DATE) AND H4 (DEVICE MANUFACTURE DATE) AS THE SPECIFIC DEVICE WAS NOT REPORTED, THESE DATES CANNOT BE ACCURATELY DETERMINED. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION 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. 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 BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 1 MONTH(S) POST-OPERATIVE OF REVISED RIGHT IMPLANTED TSA, THE PATIENT PRESENTED WITH DISLOCATION. SUBJECT WAS SWEEPING WITH THE RUE. REPORTS HEARING A "POP" WITH IMMEDIATE ONSET OF PAIN. PT. PRESENTED TO ED, WHERE THE SHOULDER WAS REDUCED, AND SHE WAS PLACED IN SLING. PT. PRESENTED TO CLINIC AFTER A VISIT TO THE ED FOR A DISLOCATION. SHE HAD BEEN SUCCESSFULLY REDUCED IN THE ED BUT PRESENTED TO CLINIC WITH AND OTHER DISLOCATION. SHE DIDN'T KNOW SHE WAS DISLOCATED AT TIME OF CLINIC PRESENTATION AND DENIES ANY INCITING TRAUMA. THIS OUTCOME OF THE EVENT WAS RESOLVED BY STANDARD REVERSE WITH HUMERAL RECONSTRUCTION STEM REVISION OF THE RIGHT SHOULDER. IT IS NOTED THAT THE PATIENT HAS SMALL BASEPLATE IMPLANTED. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) 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
    2211169 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female SEE H11