BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM

    MDR report key: 19513117 · Received June 11, 2024

    Report

    Report Number
    1038671-2024-01896
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307705
    PMA / PMN Number
    K152170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 6865339 - 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T 6840837 - 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5 6660396 - 201-78-81 - 3" TROCAR, MOD. HEX 2PK 5144609 - 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM 5735992 - 204-70-00 - TIBIAL STEM EXT. SCREW 5497072 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. 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 A 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170667 TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862307705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11