BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM

    MDR report key: 18897476 · Received March 13, 2024

    Report

    Report Number
    1038671-2024-00493
    Event Type
    Injury
    Date Received
    March 13, 2024
    Date of Event
    November 4, 2022
    Report Date
    February 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307576
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS - PRODUCT INFORMATION: 6963002 02-020-13-0325 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.5; 6269666 02-022-45-2515 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 1.5T; AB6715 1200-I - CEMEX ISOPLASTIC 40G; 6936342 200-02-32 - THREE PEG PATELLA 32MM; 7017389 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; S236872 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; S300459 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK; S303494 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK; S309208 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2022, APPROXIMATELY 11 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956498 TRULIANT TIB IMP CRC INSERT SZ 2.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862307576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention