BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM

    MDR report key: 15454492 · Received September 20, 2022

    Report

    Report Number
    1038671-2022-01139
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 29, 2022
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307811
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION . CONCOMITANT DEVICE(S): 02-020-13-0345 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4.5, 5382374, 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T, 5472550, 200-02-35 - THREE PEG PATELLA 35MM, 5495866, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S004066, A10012 - GPS IMPLANT KIT V2 06021018250.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT WAS REVISED. THE PATIENT PRESENTED TO THE CLINIC WITH PAIN AND REQUESTING THAT THE RECALLED INSERT BE REMOVED. THE SURGEON PERFORMED A POLY EXCHANGE. THE SURGEON NOTED SIGNIFICANT SYNOVITIS AND REMOVED OSTEOPHYTES AROUND THE PATELLA. THE SURGEON STATED THAT THE INSERT WAS NOT WORN SIGNIFICANTLY. EXPLANTS ARE NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FURTHER INFORMATION IS AVAILABLE FROM THE REPRESENTATIVE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 -CLINICAL CODE - FAILURE OF IMPLANT NO LONGER APPLIES, PROBLEM CODE, COMPONENT CODE RESULTS OF THE INVESTIGATION WILL BE REPORTED WITHIN 30 DAYS OF COMPLETION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT WAS REVISED. PATIENT PRESENTED CLINIC WITH PAIN AND REQUESTING RECALLED INSERT BE REMOVED. SURGEON PERFORMED A POLY EXCHANGE. HE NOTED SIGNIFICANT SYNOVITIS. HE REMOVED OSTEOPHYTES AROUND THE PATELLA. HE STATED THE INSERT WAS NOT WORN SIGNIFICANTLY. EXPLANTS NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT WAS REVISED. THE PATIENT PRESENTED TO THE CLINIC WITH PAIN AND REQUESTING THAT THE RECALLED INSERT BE REMOVED. THE SURGEON PERFORMED A POLY EXCHANGE. THE SURGEON NOTED SIGNIFICANT SYNOVITIS AND REMOVED OSTEOPHYTES AROUND THE PATELLA. THE SURGEON STATED THAT THE INSERT WAS NOT WORN SIGNIFICANTLY. EXPLANTS ARE NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FURTHER INFORMATION IS AVAILABLE FROM THE REPRESENTATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT HAS FILED A SHORT-FORM COMPLAINT. 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 THEIR POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698796 TRULIANT TIB IMP CRC INSERT SZ 4.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-51-4509 UNK 10885862307811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.