BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM

    MDR report key: 20152325 · Received September 5, 2024

    Report

    Report Number
    1038671-2024-03329
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    September 19, 2016
    Report Date
    September 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173607
    PMA / PMN Number
    K110547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 3009016032 A10012 - GPS IMPLANT KIT V2 4376257 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T 4394472 02-010-01-0235 - LOGIC FEMORAL PS CEM LEFT SZ 3.5 4495762 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM 4552552 200-02-35 - THREE PEG PATELLA 35MM 4553238 204-70-00 - TIBIAL STEM EXT. SCREW 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

    LEGAL CASE ¿ (B)(4). IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PATIENT MOBILITY AND QUALITY OF LIFE. PATIENT CURRENTLY SCHEDULED FOR A REVISION SURGERY IN (B)(6) 2024. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K110547.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887529 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862173607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown