BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 19387795 · Received May 23, 2024

    Report

    Report Number
    1038671-2024-01450
    Event Type
    Injury
    Date Received
    May 23, 2024
    Report Date
    November 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 4796499,        02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3. 5861916, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T. 5893512, 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 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.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, TYPE OF INVESTIGATION. THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND LIMITED RANGE OF MOTION AND/OR 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, "CATCHING SENSATIONS", NUMBNESS, SWELLING, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12316 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10.