BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 3, 9MM

    MDR report key: 11783804 · Received May 6, 2021

    Report

    Report Number
    1038671-2021-00217
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054241
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3) AS REPORTED, PATIENT RETURNED TO HSS 20 YEARS AFTER A TOTAL KNEE REPLACEMENT COMPLAINING OF PAIN AND INSTABILITY. THE FEMUR AND TIBIA SEEMED TO BE WELL FIXED SO THE INSERT WAS REMOVED AND A 15MM CCK INSERT WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL RETAINS ALL RETRIEVALS. UPON REVIEW OF ALL AVAILABLE INFORMATION AND DUE TO THE DEVICE NOT BEING RETURNED, THERE IS NO EVIDENCE TO SUGGEST THAT A DESIGN OR MANUFACTURING ISSUE CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED REVISION WAS LIKELY THE RESULT OF UNDERLYING PATIENT FACTORS, WHICH LED TO INSTABILITY OF THE JOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, PATIENT RETURNED TO HSS 20 YEARS AFTER A TOTAL KNEE REPLACEMENT COMPLAINING OF PAIN AND INSTABILITY. THE FEMUR AND TIBIA SEEMED TO BE WELL FIXED SO THE INSERT WAS REMOVED AND A 15MM CCK INSERT WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL RETAINS ALL RETRIEVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681768 CC TIBIAL INSERT SZ 3, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 3, 9MM UNK 10885862054241

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention| S