BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 2, 17MM

    MDR report key: 20177660 · Received September 10, 2024

    Report

    Report Number
    1038671-2024-03399
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    November 8, 2022
    Report Date
    November 7, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265906
    PMA / PMN Number
    K150890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN DUE TO PROSTHESIS WEAR. 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. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG.

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 5669559, 02-012-60-1080 - TRU STEM EXT 10MM X 80MM. 5769098, 02-012-50-2014 - TRU TIB AUG 1/2 RL SZ 2, 10MM. 6239178, 02-012-50-2013 - TRU TIB AUG 1/2 RM SZ 2, 10MM. 6536515, 208-05-02 - CC DISTAL FEM AUGMENT SZ 2, 5MM. 6765214, 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM. 6810131, 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT. 6829091, 02-012-60-1440 - TRU STEM EXT 14MM X 40MM. 7039237, 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F / 2T. 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). REFER TO (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 23 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AFFECTED MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295706 LOGIC CC TIB INSERT SIZE 2, 17MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862265906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.