BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY CR KRS

    MDR report key: 18996508 · Received March 28, 2024

    Report

    Report Number
    3004153240-2024-00007
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 22, 2024
    Report Date
    May 18, 2026
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    UDI-DI
    M572TCR000D001011
    PMA / PMN Number
    K203447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON HAS ORDERED THE FOLLOWING REPLACEMENT PARTS: ORDERED DATE, DESCRIPTION, CATALOG NUMBER, SERIAL #: 3/22/2024 ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, MEDIAL, 6MM, RIGHT RCR-020-0600-020114 (B)(6). 3/22/2024 ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, A, RIGHT RCR-020-000A-020114 (B)(6). ORIGINAL SURGERY DATE: (B)(6) 2024. NEW SURGERY DATE: (B)(6) 2024. THE SALES REP REPORTED THAT THE PATIENT WARRANTED REVISION SURGERY DUE TO AN INFECTION. THE ORIGINAL SURGERY DATE WAS (B)(6) 2024. THE NEW SURGERY DATE WAS (B)(6) 2024. THIS REPORTED INFECTION HAS OCCURRED LESS THAN 1 YEAR AFTER THE PRIMARY IMPLANT SURGERY. ACCORDING TO THE STERILIZATION RECORDS THIS SN WAS STERILIZED USING THE VHP METHOD. THIS SN WAS STERILIZED ON BATCH RUN # 2746 ON 2/14/2024. NO NCMR'S ARE ASSOCIATED WITH THIS LTS-V BATCH RUN. A REVIEW OF THIS SN RESULTED IN NO NON-CONFORMANCES AND WOULD INDICATE THE DEVICE WAS DESIGNED AND MANUFACTURED TO SPECIFICATIONS. ENDOTOXIN RESULTS WERE ALSO REVIEWED AND DID NOT RECORD ANY EXCURSIONS DURING THE PERIOD THE PRODUCT WAS PROCESSED THROUGH FINAL MANUFACTURING. INFECTION IS A KNOWN COMPLICATION OF JOINT REPLACEMENT SURGERY. BASED ON THE AVAILABLE INFORMATION, CAUSE OF INFECTION CANNOT BE CONCLUSIVELY DETERMINED TO BE RELATED TO THE DEVICE. INFECTION IS A KNOWN RISK OF TOTAL KNEE REPLACEMENT SURGERY. THE ASSOCIATED DFMEA-00012 REV AX WAS REVIEWED. RISK OF INFECTION IS ADEQUATELY CAPTURED WITHIN FMEA DOCUMENT. NO UPDATES TO RISK ANALYSIS DOCUMENTATION ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE SURGEON HAS ORDERED THE FOLLOWING REPLACEMENT PARTS: ORDERED DATE, DESCRIPTION, CATALOG NUMBER, SERIAL #: 3/22/2024. ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, MEDIAL, 6MM, RIGHT RCR-020-0600-020114, (B)(6). 3/22/2024. ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, A, RIGHT RCR-020-000A-020114. (B)(6). ORIGINAL SURGERY DATE: (B)(6) 2024. NEW SURGERY DATE: (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502106 ITOTAL IDENTITY CR KRS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CONFORMIS TCR-000-D001-020101 M572TCR000D001011

    Patients

    Seq Age Sex Outcome Treatment
    1