BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 17765101 · Received September 18, 2023

    Report

    Report Number
    1038671-2023-02293
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    August 22, 2023
    Report Date
    June 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): (B)(6), 308-02-09 - 9X120MM DISTAL STEM MODULAR CEMENTED; (B)(6), 308-05-33 - DISTAL FIXATION RING HA 33.5; (B)(6), 308-10-05 - LARGE PROX BODY +0; (B)(6), 308-15-01 - TAPER LOCKING SCREW 0; (B)(6), 320-10-10 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10; (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; (B)(6), 320-42-00 - 145-DEG PE 42MM HUM LINER +0; (B)(6), 320-42-03 - 145-DEG PE 42MM HUM LINER +2.5; (B)(6), TPA-13 - CEMENT RESTRICTOR XS (EXTRA SMALL, SZ 13).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, G3/G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN 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

    AS REPORTED, THIS 64 YEAR OLD MALE PATIENT¿S RIGHT SHOULDER WAS INITIALLY WAS IMPLANTED WITH AN COMPETITOR SHOULDER. THE PATIENT¿S SHOULDER WAS CHRONICALLY DISLOCATING AND WAS SCHEDULED FOR A REVISION OF THE HUMERAL IMPLANTS TO EXACTECH HRP IMPLANTS DUE TO PROXIMAL BONE LOSS AS WELL. THE HRP PROCEDURE WAS PERFORMED ON (B)(6) 2023 WHERE THE SURGEON IMPLANTED HRP IMPLANTS, KEPT THE COMPETITOR GLENOID IMPLANTS, AND MATCHED THE COMPETITOR GLENOSPHERE SIZE TO THE EXACTECH TRAY AND LINER CORRESPONDING SIZE. WITHIN TWO WEEKS POST-OPERATION OF THE HRP PROCEDURE ON (B)(6) THE PATIENT DISLOCATED THEIR HRP REVERSE AGAIN WHILE BEING HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. DUE TO THE CONTINUED CHRONIC DISLOCATION OF A REVERSE TSA REVISION IMPLANT, THE SURGEON SCHEDULED THE PATIENT FOR A REVISION OF THE REVERSE HRP TO A HEMI HRP. THE REVISION HRP REVERSE TO HEMI WAS PERFORMED ON (B)(6) 23. THE PATIENT WAS REVISED FROM THE COMPETITOR¿S GLENOID AND THIS MANUFACTURER¿S REVERSE TRAY AND LINER TO AN INCREASED LENGTH PROXIMAL BODY, 0MM REPLICATOR PLATE, AND A 53X28MM HUMERAL HEAD. NO GLENOID IMPLANT WAS USED, AND THE PATIENT RECEIVED A HEMI SHOULDER HRP ARTHROPLASTY. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION DUE TO THESE ISSUES. DEVICES NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332408 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male