BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    MDR report key: 19458602 · Received June 4, 2024

    Report

    Report Number
    1038671-2024-01715
    Event Type
    Injury
    Date Received
    June 4, 2024
    Report Date
    November 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    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

    H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION. MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    2971442 02-010-03-0250 - LOGIC CR FEMORAL CEM, LEFT, SZ 5 32338 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM 3882538 200-02-35 - THREE PEG PATELLA 35MM 3927419 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 46206 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19 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 THAT APPROXIMATELY 109 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED 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
    174628 LOGIC CR TIB INSERT STD, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Required Intervention SEE H11