BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 4 13MM

    MDR report key: 20179543 · Received September 10, 2024

    Report

    Report Number
    1038671-2024-03404
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    September 13, 2022
    Report Date
    September 10, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001900
    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 CONCOMITANT DEVICES: (5056714), 200-02-29 - THREE PEG PATELLA 29MM. (5X223), 203-90-03 - 11-3978 STABLECUT GTS OSC SYSTEM 6105X19X1.27. (6120377), 201-78-81 - 3"" TROCAR, MOD. HEX 2PK. (6120378), 201-78-81 - 3"" TROCAR, MOD. HEX 2PK. (6305961), 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T. (6347553), 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. (6401805), 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A RIGHT TOTAL 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
    226051 LOGIC TIBIA PS MOD INSRT SZ 4 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001900

    Patients

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