BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM

    MDR report key: 19793286 · Received July 22, 2024

    Report

    Report Number
    1038671-2024-02464
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173843
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 5032910 02-010-01-0360 - LOGIC FEMORAL PS CEM RIGHT SZ 6. 4205671 02-012-41-6050 - LOGIC TIBIA TRAPTRAY CEM SZ 6F/5T. 5484338 200-02-38 - THREE PEG PATELLA 38MM. 3609305 201-78-12 - HOLDING PIN LG HEAD SHARP POINT MED 2PK. 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 71 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS, NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, REVISION SURGERY; PAIN FOLLOWING SURGERY AND DURING THE REHABILITATION PERIOD, PHYSICAL THERAPY; LIMITED ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401678 LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173843

    Patients

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