BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 2

    MDR report key: 20498078 · Received October 21, 2024

    Report

    Report Number
    1038671-2024-04051
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    November 19, 2018
    Report Date
    October 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001214
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: (B)(6), 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T. (B)(6), 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2. (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK. (B)(6), 13A2101 - CEMEX SYSTEM FAST GENTA 70G. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL 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. (B)(6) ) (NGG) (MMH). PATIENT ID: (B)(6). CASE NO:(B)(4). IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, SWELLING, INSTABILITY, AND ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER 1764947 IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022. 02-012-35-2013 - LOGIC TIBIA PS MOD INSRT SZ 2 13MM. SERIAL: (B)(6), 510K: K033883, UDI: (B)(4), PRODUCT CODE: JWH, X-RAY: NO, OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6), 02-012-45-2030 - LGC TIBIAL FIT TRAY CEM SZ 2F / 3T. (B)(6), 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2. (B)(6), 200-02-35 - THREE PEG PATELLA 35MM. (B)(6), 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033419 LOGIC FEMORAL PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.