BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE GLENOID, KEELED BETA, MEDIUM

    MDR report key: 23179150 · Received September 30, 2025

    Report

    Report Number
    1038671-2025-02998
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 23, 2025
    Report Date
    December 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862657749
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4, D9, D10, G4, H4, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. D10: 300-01-11; 2250066 - EQUINOXE HUMERAL STEM, 11MM. 300-10-45; 2234098 - EQUINOXE REPLICATOR PLATE, 4.5MM. 300-20-02; 2231309 - EQUINOXE SQUARE TORQUE DEFINE SCREW DRIVE KIT. 310-01-47; 2296956 - EQUINOXE HUMERAL HEAD SHORT, 47MM (BETA). THE COMPLAINT DEVICE WAS EVALUATED, AND THE REPORTED EVENT WAS NOT CONFIRMED. THE EVALUATION IDENTIFIED THAT THERE APPEARS TO BE BACKSIDE DAMAGE ON THE GLENOID COMPONENT. THIS APPEARS CONSISTENT WITH TOOL MARKS LIKELY CREATED DURING REMOVAL. AS REPORTED, "THERE WERE SOME SIGNS OF WEAR PRE-REMOVAL AS THE POLY WAS SLIGHTLY LOOSE AS A RESULT OF THE INFECTION. IT WAS THEN DAMAGED FURTHER WHEN BEING "LEVERED" OUT VIA AN OSTEOTOME WHEN EXTRACTED." THERE APPEARS TO BE CEMENT STILL ADHERED TO THE BACKSIDE OF THE KEELED COMPONENT. THERE APPEARS TO BE DAMAGE ON THE ARTICULAR SURFACE. THIS APPEARS CONSISTENT WITH THE TOOL DAMAGE NOTED, THAT HAS EXTENDED THROUGH THE BODY OF THE POLYETHYLENE. OVERALL, THERE APPEARS TO BE WEAR ACROSS THE ARTICULAR SURFACE CONSISTENT WITH ARTICULATION WITH THE HUMERAL HEAD AND OVER 13 YEARS OF USE. THERE APPEARS TO BE MINOR SCRATCHING ON THE ARTICULAR SURFACE OF THE HUMERAL HEAD. THIS MAY HAVE OCCURRED DURING REMOVAL OF THE COMPONENT. NO ALLEGATIONS WERE MADE AGAINST THIS DEVICE. THERE APPEARS TO BE RESIDUAL BONE/BONE CEMENT ADHERED TO THE SURFACE OF THE STEM. ADDITIONALLY, THERE APPEARS TO BE SCRATCHING AND DAMAGE ON THE SURFACE OF THE STEM. THIS WAS LIKELY CREATED DURING REMOVAL AND/OR CLEANING OF THE DEVICE. NO ALLEGATIONS WERE MADE AGAINST THIS DEVICE. THE TORQUE SCREW APPEARS UNREMARKABLE FOR AN EXPLANTED COMPONENT. NO ALLEGATIONS WERE MADE AGAINST THIS DEVICE. ALL OTHER ASPECTS OF THE DEVICES APPEAR UNREMARKABLE. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM AN INFECTION WITH SUBSEQUENT LOOSENING OF THE GLENOID COMPONENT. THE REASON FOR THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AS THE DEVICES WERE IMPLANTED FOR 13 YEARS. THE OBSERVED WEAR ON THE ARTICULAR SURFACE OF THE GLENOID COMPONENT WAS LIKELY THE RESULT OF OVER 13 YEARS OF USE AND ARTICULATION WITH THE HUMERAL HEAD.

    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.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT UNDERWENT A RIGHT INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION. THERE WERE SOME SIGNS OF WEAR OF THE POLY PRE-REMOVAL, AS THE POLY WAS SLIGHTLY LOOSE AS A RESULT OF THE INFECTION. IT THEN DAMAGED FURTHER WHEN BEING "LEVERED" OUT VIA ON OSTEOTOME WHEN EXTRACTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR 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
    2215837 EQUINOXE GLENOID, KEELED BETA, MEDIUM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862657749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization