BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 2.5 9MM

    MDR report key: 17282835 · Received July 7, 2023

    Report

    Report Number
    1038671-2023-01587
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    May 25, 2023
    Report Date
    March 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304162
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10. CONCOMITANTS: 5169891, 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5; 5060873, 02-022-45-2515 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T; 5187466, 200-02-32 - THREE PEG PATELLA 32MM; 5261933, 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM; 5175535, 204-70-00 - TIBIAL STEM EXT. SCREW.

    Additional Manufacturer Narrative · 0

    THIS HAS BEEN DISCOVERED TO BE A DUPLICATE CASE AND WILL BE CLOSED; ALL NEW AND ADDITIONAL INFORMATION WILL BE PROCESSED AND REPORTED IN MFR # 1038671-2023-01403.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2018. THEY UNDERWENT SUBSEQUENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS AFTER THEIR PRIMARY REPLACEMENT. ON (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: LEFT TOTAL KNEE REVISION INSTABILITY OF LEFT KNEE. INTRAOPERATIVE FINDING INDICATED THAT THERE WAS SEVERE SYNOVITIS. THE POLYETHYLENE LINER APPEARED TO HAVE VERY MINIMAL WEAR, BUT THERE WAS MEDIAL LATERAL INSTABILITY THROUGHOUT THE RANGE OF MOTION. THERE WAS SEVERE WEAR OF THE PATELLAR COMPONENT. VERY MINIMAL OSTEOLYSIS WAS NOTED IN THE ANTERIOR FEMUR JUST PROXIMAL TO THE INTERCONDYLAR NOTCH. THE FEMORAL COMPONENT APPEARED TO BE WELL FIXED. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039027 TRULIANT TIB IMP PS INSERT SZ 2.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-022-35-2509 UNK 10885862304162

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention