BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM HUM LINER +0

    MDR report key: 22559630 · Received July 21, 2025

    Report

    Report Number
    1038671-2025-02533
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    July 10, 2024
    Report Date
    October 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. D10: (B)(6) A10012 - GPS IMPLANT KIT V2. (B)(6) 314-13-34 - EQUINOXE CAGE GLENOID L, POST AUG, RIGHT. (B)(6) 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA). (B)(6) 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. (B)(6) 300-30-09 - EQUINOXE PRESERVE STEM 9MM. (B)(6) 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. (B)(6) 531-78-20 - SHOULDR GPS HEX PINS KIT. (B)(6) 531-78-20 - SHOULDR GPS HEX PINS KIT. (B)(6) 315-35-00 - GLND KWIRE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: A2, B3, B4, B5, D1, D2A, D2B, D4, D6A, D6B, D10, G3, G4, H4, H6. D10: 08011017016 A10012 - GPS IMPLANT KIT V2. 4843732 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 4848938 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. 4974584 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 4979760 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 4980729 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 4986362 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 5012158 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE. 5075479 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 5081787 320-15-05 - EQ REV LOCKING SCREW. 5087106 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 5118312 320-15-04 - RS GLENOID PLATE POST AUG, 8 DEG.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G3.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11 NO DEVICE WAS RETURNED FOR EVALUATION; PHOTOGRAPHS OF THE DEVICE WERE PROVIDED; HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE REVIEW IDENTIFIED THAT THE HUMERAL LINER APPEARS TO HAVE NOTABLE WEAR ON THE SUPERIOR RIM OF THE ARTICULAR SURFACE. THIS WEAR COULD BE CONSISTENT WITH IMPINGEMENT BETWEEN THE LINER AND THE SUPERIOR ASPECT OF THE GLENOID. IT IS ALSO POSSIBLE THAT THERE WAS INTRA-ARTICULAR FORCE ON THE SUPERIOR RIM. IN ADDITION, THE ARTICULAR SURFACE OF THE LINER APPEARS TO BE SLIGHTLY DISCOLORED AND ROUGHENED, WHICH COULD BE CONSISTENT WITH THE IMPACT OF AN INFECTION. THE INFECTION ALSO COULD HAVE EXACERBATED THE ABRASIVE WEAR SEEN ON THE SUPERIOR PORTION OF THE DEVICE. 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 PROSTHESIS WEAR, INFECTION, AND/OR INCLUSION OF THE POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. HOWEVER, THE INFECTION CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS FROM USER OR PATIENT-RELATED CONSIDERATIONS CANNOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WAS 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

    AS REPORTED, APPROXIMATELY 2 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A LOOSE GLENOID COMPONENT WITH MARKED OSTEOLYSIS OF THE GLENOID DUE TO POLYETHYLENE WEAR. EVERYTHING WAS REMOVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY). SUBSEQUENTLY, THE PATIENT DEVELOPED POLY WEAR THEN DEVELOPED INFECTION DUE TO A BIOPSY. AS A RESULT, THE SURGEON REVISED EVERYTHING AND A CEMENT SPACER WAS PLACED 6.5 YEARS POST THE INITIAL OPERATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035817 145-DEG PE 42MM HUM LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization SEE H11.| SEE H11.