BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CC TIB INSERT SIZE 2, 21MM

    MDR report key: 20171514 · Received September 9, 2024

    Report

    Report Number
    1038671-2024-03375
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    March 26, 2022
    Report Date
    October 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265920
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND INSTABILITY. THE REPORTED PROSTHESIS WEAR AND INSTABILITY COULD NOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. ADDITIONALLY, THIS DEVICE WAS PACKAGED AFTER INITIATION OF THE RECALL AND WAS NOT PACKAGED IN A NON-CONFORMING VACUUM BAG H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 18818 CS-10CC - INTERSEP CALCIUM SULFATE; 4758501 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T; 5408248 02-012-60-1280 - TRU STEM EXT 12MM X 80MM; 5669548 02-012-60-1080 - TRU STEM EXT 10MM X 80MM; 6743839 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT; 7090519 200-02-35 - THREE PEG PATELLA 35MM; AB7921 1400-AG - CEMEX GENTO LOW VISCOSITY 40G KIT. 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 4 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, AND POPPING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020967 LOGIC CC TIB INSERT SIZE 2, 21MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862265920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.