BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 13MM

    MDR report key: 18871225 · Received March 8, 2024

    Report

    Report Number
    1038671-2024-00439
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    February 16, 2024
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B4, G, H6 TYPE OF INVESTIGATION, H6 INVESTIGATION FINDINGS, H6 INVESTIGATION CONCLUSION CORRECTION: H6 PROBLEM CODE, H6 CLINICAL CODE, H6 COMPONENT CODE

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 6280076 - 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. 6256320 - 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 6207552 - 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T 6161385 - 200-02-32 - THREE PEG PATELLA 32MM. 6274241 204-70-00 - TIBIAL STEM EXT. SCREW. 7025019197 A10012 - GPS IMPLANT KIT V2. H7: Z-0023-2022.

    Additional Manufacturer Narrative · 0

    H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. THE REASON FOR THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PRESUMED PROSTHESIS WEAR, INSTABILITY AND DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. THERE DOES NOT APPEAR TO BE EVIDENCE OF PROSTHESIS WEAR ON THE TIBIAL INSERT; HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 51 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2024. THE TIBIAL INSERT WAS EXCHANGED DUE TO THE RECALL AND A SIZE 3 17MM TIBIAL LINER WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156957 TRULIANT TIB IMP PS INSERT SZ 3 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention