BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM

    MDR report key: 20153208 · Received September 5, 2024

    Report

    Report Number
    1038671-2024-03332
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    February 8, 2023
    Report Date
    September 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174413
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "CONCOMITANTS: (B)(6), 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3. (B)(6), 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK. (B)(6), 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK. (B)(6), 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. (B)(6), 200-02-32 - THREE PEG PATELLA 32MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022. 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

    LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K111400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073924 LOGIC CR TIB INSERT SLOPE++, SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862174413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.