BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IC-BIPOLAR HEAD COCRMO Ø 28 / 44 MM

    MDR report key: 22184221 · Received June 11, 2025

    Report

    Report Number
    3012523063-2025-00060
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 13, 2025
    Report Date
    August 19, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    KWY
    PMA / PMN Number
    K191569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT A DIRT PARTICLE WAS SEALED IN THE PACKAGING OF AN IC-BIPOLAR HEAD COCRMO Ø 28/44 MM. ACCORDINGLY, THE IMPLANT WAS NOT USED, AND AN ALTERNATIVE PRODUCT HAD TO BE RETRIEVED FROM THE STORAGE, WHICH RESULTED IN A PROLONGATION OF SURGERY TIME BY 15 MINUTES. OPTICAL EXAMINATION OF THE IMPLANT CONFIRMED THE PRESENCE OF A FREELY MOVING BLACK PARTICLE INSIDE OF THE STERILE PACKAGING. AN INTERNAL INVESTIGATION REVEALED THAT THIS IS A PARTICLE OF TEXTILE ORIGIN. THE PARTICLE PROBABLY CAME INTO CONTACT WITH THE PRODUCT DURING THE PACKAGING PROCESS AND SHOULD HAVE BEEN DETECTED LATEST DURING THE PACKAGING INSPECTION. HOWEVER, DUE TO AN ISOLATED CASE OF HUMAN ERROR, THE PARTICLE HAS BEEN OVERLOOKED IN THE VISUAL INSPECTION. NEVERTHELESS, DESPITE OF THE INCIDENT, A FUNCTIONAL, STANDARD-COMPLIANT CLEANING AND MONITORING SYSTEM IS IMPLEMENTED IN THE CLEANROOM AREA IN QUESTION. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND THE SURGICAL TECHNIQUES WERE REVIEWED, NONE OF WHICH INDICATED ANY DEVIATION. IN CONCLUSION, THE AVAILABLE DATA INDICATE THAT THE INCIDENT WAS CAUSED BY QUALITY CONTROL DEFICIENCY RESULTING FROM AN INDIVIDUAL HUMAN ERROR. THE RELEVANT EMPLOYEES WILL BE TRAINED AND SENSITISED IN ORDER TO AVOID SUCH INCIDENTS IN THE FUTURE. THE EVENT WAS ASSIGNED TO THE HAZARD "RESIDUES / PARTICLES ON IMPLANT" IN THE ASSOCIATED RISK MANAGEMENT OVERVIEW.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE IMPLANTCAST GMBH THAT A DIRT PARTICLE WAS SEALED IN THE PACKAGING OF AN IC-BIPOLAR HEAD COCRMO Ø 28/44 MM. ACCORDINGLY, THE IMPLANT WAS NOT USED, AND AN ALTERNATIVE PRODUCT HAD TO BE RETRIEVED FROM THE STORAGE, WHICH RESULTED IN A PROLONGATION OF SURGERY TIME BY 15 MINUTES. OPTICAL EXAMINATION OF THE IMPLANT CONFIRMED THE PRESENCE OF A FREELY MOVING BLACK PARTICLE INSIDE OF THE STERILE PACKAGING. THE ORIGIN OF THE PARTICLE IS NOT DETERMINABLE AT THE PRESENT TIME. THE MANUFACTURING DOCUMENTS, INSTRUCTIONS FOR USE AND THE SURGICAL TECHNIQUES WERE REVIEWED, NONE OF WHICH INDICATED ANY DEVIATION. NEVERTHELESS, THE ERROR PATTERN INDICATES THAT AN ERROR OCCURRED DURING THE PACKAGING PROCESS. THE EVENT WAS ASSIGNED TO THE HAZARD "RESIDUES / PARTICLES ON IMPLANT" IN THE ASSOCIATED RISK MANAGEMENT OVERVIEW. IN CONCLUSION, THE AVAILABLE DATA SUGGEST THAT THE INCIDENT WAS CAUSED BY A MANUFACTURING / QUALITY CONTROL DEFICIENCY RESULTING FROM AN INDIVIDUAL HUMAN ERROR. A COMPREHENSIVE INVESTIGATION OF THE CAUSES HAS BEEN INITIATED. THE RELEVANT EMPLOYEES WILL BE TRAINED AND SENSITISED IN ORDER TO AVOID SUCH INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DIRT PARTICLES SEALED INTO THE IMPLANT PACKAGING." (TRANSLATED FROM GERMAN: "SCHMUTZPARTIKEL BEIM IMPLANTAT MIT EINGESCHWEISST"). REMARK IMPLANTCAST GMBH: A FOLLOW UP REPORT HAS BEEN COMPILED DUE TO THE RESULTS OF THE INTERNAL INVESTIGATION.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DIRT PARTICLES SEALED INTO THE IMPLANT PACKAGING." ( TRANSLATED FROM GERMAN: "SCHMUTZPARTIKEL BEIM IMPLANTAT MIT EINGESCHWEISST").

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94454 IC-BIPOLAR HEAD COCRMO Ø 28 / 44 MM BIPOLAR HEAD KWY IMPLANTCAST GMBH 21510044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention