BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU CC FEMORAL SIZE 4 LEFT

    MDR report key: 20048599 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03040
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265678
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: OPTETRAK FEMORAL AUG BLOCK & SCREW (208-05-04, (B)(6)); OPTETRAK LOGIC FIT TIBIAL TRAY (02-012-45-4030, (B)(6)); OPTETRAK LOGIC STEM EXTENSION FEMORAL AND TIBIAL (02-012-60-1440, (B)(6)); OPTETRAK TIBIAL STEM EXTENSION SCREW (204-70-00, (B)(6)); OPTETRAK FEMORAL AUG BLOCK & SCREW (208-05-04, (B)(6)); OPTETRAK LOGIC STEM EXTENSION FEMORAL AND TIBIAL (02-012-60-1440, (B)(6)); OPTETRAK LOGIC FEMORAL AUGMENT & SCREW POSTERIOR, CEMENTED (02-010-06-0541, (B)(6)); OPTETRAK LOGIC FEMORAL AUGMENT & SCREW POSTERIOR, CEMENTED (02-010-06-0541, (B)(6)); COMPETITOR STEM TRULIANT TIBIAL INSERT (02-022-35-4013, (B)(6)). 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

    1038671-2023-02332, 1038671-2024-03038 CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT#:1038671-2023-02332 AND #: 1038671-2024-03038.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS 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
    2072280 TRU CC FEMORAL SIZE 4 LEFT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862265678

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H SEE H11.