BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 17167710 · Received June 20, 2023

    Report

    Report Number
    1038671-2023-01408
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6666991: 320-15-01 - EQ REV GLENOID PLATE. 6929490: 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT. 6990026: 320-06-38 - GLENOSPHERE 38MM. 7043614: 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 7106307: 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 7204211: 320-15-05 - EQ REV LOCKING SCREW. S114126: 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S284269: 320-38-00 - 145-DEG PE 38MM HUM LINER +0. S310473: 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S310808: 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S331320: 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, DISLOCATION, ROTATOR CUFF TEAR, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, WITH IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. 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

    IT WAS REPORTED THAT A 73 YO FEMALE PATIENT, WHO HAD A PREVIOUS RIGHT-SIDE REVISION IN WHICH HER GLENOID COMPONENT FAILED DUE TO POOR BONE QUALITY, ¿SHE HAD BEEN RADIATED AND HAD POOR GENERAL HEALTH¿, HAD UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2023. THE ORIGINAL PLAN WAS TO EITHER REVISE JUST THE GLENOID IF POSSIBLE OR CONVERT TO HEMI IF NOT. BOTH GLENOID AND HUMERAL COMPONENTS WERE POORLY FIXED, SO A FRACTURE STEM WAS CEMENTED IN AS A HEMI. THERE WERE NO DEVICE BREAKAGES, OR SURGICAL DELAYS REPORTED. UNKNOWN MEDICAL HISTORY. NO X-RAYS WERE PROVIDED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO THE HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013956 EQUINOXE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. EQUINOXE PRESERVE STEM 9MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female SEE H10