BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4 11MM

    MDR report key: 19509197 · Received June 11, 2024

    Report

    Report Number
    1038671-2024-01883
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    July 26, 2023
    Report Date
    March 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304452
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5734125, 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4. 5746953, 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. 5786914, 200-02-35 - THREE PEG PATELLA 35MM. 5789636, 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F/4T. 5844773, 204-70-00 - TIBIAL STEM EXT. SCREW. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0023-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS THE CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 53 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. DURING THE PROCEDURE IT WAS NOTED THE TIBIAL POLYETHYLENE COMPONENT SHOWED A VISIBLE AMOUNT OF POLYETHYLENE WEAR WITHIN THE WEIGHTBEARING PORTIONS OF THE POLYETHYLENE. THERE WAS SOME PITTING OF THE POLYETHYLENE COMPONENT AND SOME WEAR ON THE BACK SIDE OF THE TIBIAL POST. A MODERATE AMOUNT OF POLYETHYLENE DEBRIS WAS FOUND WITHIN THE ENCAPSULATED SYNOVIAL TISSUE. A COMPLETE SYNOVECTOMY WAS PERFORMED. THE TIBIAL, FEMORAL, AND PATELLAR COMPONENTS WERE FOUND TO BE WELL-FIXED. FOLLOWING THE PROCEDURE THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813864 TRULIANT TIB IMP PS INSERT SZ 4 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H