BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK KNEE COMPONENT - TIBIAL INSERT

    MDR report key: 19694286 · Received July 8, 2024

    Report

    Report Number
    1038671-2024-02318
    Event Type
    Injury
    Date Received
    July 8, 2024
    Report Date
    July 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 5282983 02-010-01-0340 - LOGIC FEMORAL PS CEM RIGHT SZ 4 2005844 02-012-35-4011 - LOGIC TIBIA PS MOD INSRT SZ 4 11MM 4454364 02-012-35-4013 - LOGIC TIBIA PS MOD INSRT SZ 4 13MM 4641795 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 5187046 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T 5250955 200-02-35 - THREE PEG PATELLA 35MM 5310376 200-02-35 - THREE PEG PATELLA 35MM. 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 THE 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 75 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND MAY REQUIRE A FUTURE REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151878 OPTETRAK KNEE COMPONENT - TIBIAL INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11