BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15502468 · Received September 29, 2022

    Report

    Report Number
    1038671-2022-01193
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 7, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862315113
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED AS THEY ARE NOT AVAILABLE FOR RETURN. CONCOMITANTS: Z062345, 02-022-51-3009 - TRULIANT TIB IMP CRC INSERT SZ 3, 9MM, 7083097, 02-022-55-3030 - TRULIANT POR TIB TRAY SIZE 3F/3T, 6948376, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK, 6947680, 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM, S316204, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK, S300583, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, S317555, 21-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, 3008421308, A10012 - GPS IMPLANT KIT V2. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: 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. THE CRACK OF THE MEDIAL CONDYLE WAS NOTED DURING IMPACTION AND ROTATION OF THE FEMUR, THIS WAS MOST LIKELY DUE TO THE PROCEDURE.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, PRESENTED TO THE CLINIC WITH PAIN AND INSTABILITY. THE MECHANICAL CUTS APPEARED GOOD ON X-RAY BUT THE PATIENTS MCL APPEARED TO BE NOT FUNCTIONING WITH NOTABLE GAPPING MEDIALLY. A REVISION WAS PERFORMED ON (B)(6) 2022, APPROXIMATELY 9 MONTHS POST THE INITIAL IMPLANT PROCEDURE. LATERAL RELEASES AND THICKER POLY DID NOT SOLVE THE MID FLEXION INSTABILITY, SO THE PREVIOUS POROUS FEMUR WAS CONVERTED TO A STEMMED CC FEMUR WITH A CC INSERT. DURING THE PROCEDURE, A SLIGHT CRACK OF THE MEDIAL CONDYLE WAS NOTED DURING IMPACTION OF THE FEMUR, WHICH OCCURRED DURING IMPACTION AND ADJUSTING ROTATION. THE NEW IMPLANTS WERE STABLE WITH GOOD ROM AND THE INSTABILITY WAS SIGNIFICANTLY BETTER PER THE SURGEON. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. PRODUCT NOT RETURNING - EXPLANTS NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CRACK HAPPENED DURING IMPACTION AND ADJUSTING ROTATION. NO OTHER INFORMATION IS AVAILABLE TO THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767772 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT CR POR FEM CR POR RIGHT SZ 3 UNK 10885862315113

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10