BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 20655154 · Received November 11, 2024

    Report

    Report Number
    1038671-2024-04336
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    February 28, 2024
    Report Date
    January 31, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4:510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED THE FOLLOWING SECTIONS WERE UPDATED: D8. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE CAUSE OF THE PATIENT¿S DEEP WOUND DEHISCENCE INCLUDING RUPTURE OF THE PATELLAR TENDON REPORTED APPEARS TO BE RELATED TO TRAUMA TO THE SURGICAL INCISION SITE. THE EVENT AS DESCRIBED APPEARS UNRELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICES. 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

    (D10) REPORTED CONCOMITANT DEVICE(S): 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2 (B)(6); 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T (B)(6); 02-012-35-2009 - LOGIC TIBIA PS MOD INSRT SZ 2 9MM (B)(6); 200-02-26 - THREE PEG PATELLA 26MM (B)(6).

    Description of Event or Problem · 0

    APPROXIMATELY 8 DAY(S) POST-OPERATIVE OF A RIGHT TKA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A FALL FROM HIS OWN HEIGHT, CAUSING THE WOUND TO BREAK DOWN. ON THE SAME DAY, IQX DEBRIDEMENT AND CLOSURE OF THE ARTHROTOMY + QUADRICIPITAL T WERE PERFORMED. NOTE: DEHISCENCE OF THE DISTAL WOUND AND RUPTURE OF THE QUADRICIPITAL TENDON WAS OBSERVED (PRACTICALLY IN ITS ENTIRE THICKNESS), DEBRIDEMENT, LAVAGE, ARTHROTOMY CLOSURE AND QUADRICIPITAL T TENORRHAPHY WERE PERFORMED. THE PATIENT WAS THEN DISCHARGED HOME. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630749 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention