BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITOTAL IDENTITY POSTERIOR STABILIZING KRS

    MDR report key: 20733489 · Received November 20, 2024

    Report

    Report Number
    3004153240-2024-00022
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 20, 2024
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K230846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR AND NCRS WERE REVIEWED. NO ISSUES IDENTIFIED WITHIN THE DHR RECORD. NO OPEN OR CLOSED NCRS LINKED TO THE SERIAL NUMBER AFFECTED. BREACH OF THE STERILE BARRIER IS COVERED WITHIN FMEA-02642 REV BQ ON LINE 54. SEVERITY RANKING OF 9, OCCURRENCE RANKING OF 3 (1 IN 5000) AND DETECTION RANKING OF 3 (7 OUT OF 10). AFTER EVALUATING THE POTENTIAL SCENARIOS, THE DEFECT FOUND IN THE FIELD PER (B)(4) IS NOT PER A STAPLE PUNCTURING THE POUCH WITHIN THE RESTOR3D (CONFORMIS) FACILITY IN WILMINGTON, MA. THE ROOT CAUSE IS UNKNOWN AS A WALKTHROUGH/INVESTIGATION WAS CONDUCTED IN THE ONLY POTENTIALLY LINKED THREE AREAS (CLEAN ROOM, FINAL PACKAGING AND FINAL QA RELEASE) AND NO OTHER TOOLS, EQUIPMENT OR POTENTIAL CAUSES WERE IDENTIFIED THAT WOULD CREATE THIS TYPE OF BREACH IN THE STERILE BARRIER OF THE POUCH. DEFECT COULD HAVE POTENTIALLY OCCURRED OUTSIDE OF THE RESTOR3D NORTH FACILITY. ROOT CAUSE UNKNOWN

    Description of Event or Problem · 0

    PLEASE FIND THIS AS A FORMAL COMPLAINT FOR THIS CASE WHERE THE IMPLANT PACKAGING WAS VIOLATED AND APPEARS PERFORATED BY A STAPLE. THE JIGS WERE FINE AND NOT DAMAGED. THE CASE WAS DELAYED TO STERILIZE THE IMPLANT COMPONENT, THE CASE WAS THEN COMPLETED WITHOUT FURTHER IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070088 ITOTAL IDENTITY POSTERIOR STABILIZING KRS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CONFORMIS TPS-000-D001-010101

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Unknown Other