BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21148962 · Received January 14, 2025

    Report

    Report Number
    1038671-2025-00235
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 12, 2024
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. CONCOMITANTS: 7232710, 300-01-12 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; 6315916, 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S; 7274039, 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; 6986328, 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA); 5951179, 314-13-14 - EQUINOXE CAGE GLENOID LARGE, BETA; A010605, 321-52-09 - 3.2MM K-WIRE, TROCAR TIP.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF ROTATOR CUFF DETERIORATION AND SUBSEQUENT SUPERIOR MIGRATION OF THE HUMERAL HEAD RESULTING IN PROSTHESIS WEAR OF THE GLENOID COMPONENT. THE REASON FOR THE ROTATOR CUFF FAILURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, COMPONENT SIZING OR POSITIONING ISSUES, OR A COMBINATION OF THE ABOVE. D1: CORRECTED. H6: CORRECTED COMPONENT AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS AND 5 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT HAD A DEFICIENT ROTATOR CUFF TEAR AND REQUIRED CONVERSION TO A REVERSE TSA. PER THE SURGEON, THE IMPLANTS WERE WELL FIXED AND NOT A PROBLEM WITH THE IMPLANTS. ALL IMPLANTS WERE REMOVED EXCEPT FOR THE STEM WHICH WAS WELL FIXED. A STANDARD BASEPLATE WITH A 38MM GLENOSPHERE WAS RE-IMPLANTED ALONG WITH A +0 TRAY AND +0 POLY. THE SURGEON TOOK THROUGH RANGE OF MOTION AND WAS HAPPY WITH THE END RESULT. THE EVENT WAS UNRELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516078 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention SEE H11.