BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM

    MDR report key: 20145150 · Received September 5, 2024

    Report

    Report Number
    1038671-2024-03305
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    April 25, 2023
    Report Date
    September 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174390
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCTS: 2553810 - 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. 2667409 - 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F/3T. 1593432 - 200-03-32 - ONE PEG PATELLA 32MM. 2640030 - 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK. 31131 - 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. 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 THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY, TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073413 LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174390

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H SEE H11.