BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 17125818 · Received June 14, 2023

    Report

    Report Number
    1038671-2023-01339
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 2, 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), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; (B)(6), 320-15-01 - EQ REV GLENOID PLATE; (B)(6), 320-15-05 - EQ REV LOCKING SCREW; (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; (B)(6), 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; (B)(6), 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6), 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6), 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6), 320-38-00 - 145-DEG PE 38MM HUM LINER +0; (B)(6), 652-00-05 - OPTECURE WITH CCC - 5CC.

    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, G4,, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. 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 1 MONTH POST OP, THIS 67 Y/O MALE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO AN ACUTE INFECTION. THE PATIENT HAD AN ANATOMIC TOTAL SHOULDER REVISED TO A REVERSE ON (B)(6)2023. THE PATIENT WAS OBSERVED TO HAVE ABNORMAL REDNESS & DISCOMFORT AROUND THE AREA OF THE INCISION. LABS INDICATED INFECTION. THE SURGEON REMOVED THE LINER, TORQUE SCREW, TRAY, GLENOSPHERE SCREW, & GLENOSPHERE. THE SITE WAS THOROUGHLY FLUSHED. THEN, THE NECESSARY IMPLANTS WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL PATIENT INFORMATION GIVEN. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING DUE TO HOSPITAL COMPANY POLICY. DO YOU KNOW THE INITIAL IMPLANT DATE (INDEX SURGERY DATE)? KNOWN. PROVIDE THE INITIAL IMPLANT DATE (INDEX SURGERY DATE) (B)(6)2023 SERIAL NUMBER: (B)(6), ITEM NUMBER AND FULL DESCRIPTION: 320-06-38 - GLENOSPHERE 38MM. 510(K) NUMBER: K193098. CONCOMITANTS: (B)(6), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; (B)(6), 320-15-01 - EQ REV GLENOID PLATE; (B)(6), 320-15-05 - EQ REV LOCKING SCREW; (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; (B)(6), 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; (B)(6), 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6), 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6), 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6), 320-38-00 - 145-DEG PE 38MM HUM LINER +0; (B)(6), 652-00-05 - OPTECURE WITH CCC - 5CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874184 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male