BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 11MM

    MDR report key: 18088129 · Received November 7, 2023

    Report

    Report Number
    1038671-2023-02712
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    June 22, 2020
    Report Date
    April 18, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    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

    THE PROSTHESIS WEAR REPORTED MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NEITHER RADIOGRAPHS, PHOTOGRAPHS OR OPERATIVE NOTES WERE PROVIDED. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED WEAR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: (B)(6) -02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM. (B)(6)-02-012-60-1480 - TRU STEM EXT 14MM X 80MM. (B)(6)-02-010-06-0330 - TRU CC FEMORAL SIZE 3 RIGHT. (B)(6)-201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK . (B)(6)-02-012-60-1440 - TRU STEM EXT 14MM X 40MM. (B)(6)-02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. (B)(6)-204-70-00 - TIBIAL STEM EXT. SCREW. (B)(6)-521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. (B)(6)-521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REVISION SURGERY ON (B)(6)2020. THEY HAVE NOT YET UNDERGONE A 2ND REVISION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. 2022 CA (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175072 TRULIANT TIB IMP PS INSERT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862304278

    Patients

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