BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4, 13MM

    MDR report key: 19152770 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00917
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    January 11, 2023
    Report Date
    October 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307774
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR AND/OR DECREASED RANGE OF MOTION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES 5949173 - 02-012-50-3011 - TRU TIB AUG 1/2 SIZE 3, 5MM 6933772 - 02-012-50-3011 - TRU TIB AUG 1/2 SIZE 3, 5MM 6237501 - 02-012-50-3013 - TRU TIB AUG 1/2 RM SZ 3, 10MM 6126068 - 02-012-50-9015 - TRU TIBIAL AUG SCREW 15MM 6287708 - 02-012-60-1680 - TRU STEM EXT 16MM X 80MM 5789110 - 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T 6619130 - 204-70-00 - TIBIAL STEM EXT. SCREW H3: THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO LOOSENING IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE LOOSENING OF THE TIBIAL COMPONENT. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN WAS REVISED ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, AND DECREASED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241727 TRULIANT TIB IMP CRC INSERT SZ 4, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862307774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10