BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 3, 15MM

    MDR report key: 19124886 · Received April 17, 2024

    Report

    Report Number
    1038671-2024-00892
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    November 1, 2023
    Report Date
    October 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305138
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED, BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 7100961 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 5800605 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T A031202 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK S364422 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK S365465 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY SECOND REVISION ON (B)(6) 2022, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED.THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231534 TRULIANT TIB IMP PSC INSERT SZ 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305138

    Patients

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