BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3, 9MM

    MDR report key: 19197057 · Received April 26, 2024

    Report

    Report Number
    1038671-2024-00998
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    June 21, 2023
    Report Date
    November 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307637
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 03009021137 A10012 - GPS IMPLANT KIT V2 WEST, CYNTHIA. 5681453 02-020-14-0330 - TRULIANT CR POR FEM CR POR RIGHT SZ 3 WEST, CYNTHIA. 6737458 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM WEST, CYNTHIA. 6841260 02-022-55-3020 - TRULIANT POR TIB TRAY SIZE 3F/2T WEST, CYNTHIA. 6907733 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK WEST, CYNTHIA. S265322 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK WEST, CYNTHIA. S265534 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK WEST, CYNTHIA. S265576 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK WEST, CYNTHIA. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT. THE CAUSE OF PROSTHESIS WEAR IS GENERALLY A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICES: (B)(6) A10012 - GPS IMPLANT KIT V2; (B)(6) 02-020-14-0330 - TRULIANT CR POR FEM CR POR RIGHT SZ 3; (B)(6) 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM; (B)(6) 02-022-55-3020 - TRULIANT POR TIB TRAY SIZE 3F/2T; (B)(6) 201-78-15 - HOLDING PIN MINI SHARP POINT 4 P; (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK; (B)(6) 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK; (B)(6) 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, H6. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY 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 KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND THEN WAS REVISED ON (B)(6) 2023. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, SCARRING, NUMBNESS, INFLAMMATION, KNEE POPPING AND CLICKING, INSTABILITY, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039118 TRULIANT TIB IMP CRC INSERT SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862307637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H