BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5

    MDR report key: 19048164 · Received April 4, 2024

    Report

    Report Number
    1038671-2024-00745
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    August 5, 2020
    Report Date
    July 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086723
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 6528876. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6429883. 320-15-05 - EQ REV LOCKING SCREW: 6520143. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6486713. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6525408. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL 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

    STUDY: EQUINOXE SHOULDER STUDY. SUBJECT: (B)(4). RELATED TO: CASE: (B)(4). IMPLANT DATE: ON (B)(6) 2020. EX-PLANT DATE: ON (B)(6) 2020. DATE OF EVENT ONSET: 08-05-2020. ADVERSE EVENT NAME : SUPERFICIAL INFECTION. SERIOUS ADVERSE EVENT? YES. AE RELATED TO DEVICE? DEFINITELY NOT RELATED. AE RELATED TO PROCEDURE? POSSIBLY RELATED. ACTION TAKEN: REVISION - STANDARD REVERSE W-PRESERVE STEM, OTHER - IRRIGATION AND DEBRIDEMENT SCHEDULED FOR ON (B)(6) 2020. REVISION DATE: ON (B)(6) 2020. OUTCOME: RESOLVED. P/N: 320-42-13. DEVICE NAME: EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5. S/N: (B)(6) CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K063569. UDI: (B)(4). PRODUCT CODE: KWT. CONCOMITANTS: 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET: 6528876. 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: 6429883. 320-15-05 - EQ REV LOCKING SCREW : 6520143. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6486713. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 6525408. 69-YEAR-OLD WHITE MALE. HEIGHT: 72 IN. BMI: 30. PREVIOUS SURGERY ON INVOLVED SHOULDER? YES - 1999- OPEN ROTATOR CUFF REPAIR, ON (B)(6) 2018- REVERSE SHOULDER ARTHROPLASTY. DIAGNOSIS: OTHER - DISSOCIATED POLYETHYLENE COMPONENT, RECURRENT INSTABILITY EPISODES COMORBIDITIES: HYPERTENSION, OTHER - HYPOTHYROIDISM, HYPERCHOLESTEROLEMIA UNSPECIFIED ANALGESIC USE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED. EBI IMPLANTATION SURGERY RESULTS ATTACHED. HISTORICAL RECORDS, SMART SOLVE, AND INBOX SEARCHED FOR DUPLICATE CASES BY SERIAL NUMBERS AND/OR CLINICAL TRIAL SUBJECT WITH NO RESULTS. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267460 EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086723

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male SEE H10.