BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV F TIB.OFFSET CEMENT.T1

    MDR report key: 12605085 · Received October 11, 2021

    Report

    Report Number
    9610612-2021-00652
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 11, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    UDI-DI
    04046963175948
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A COLUMBUS REV F TIB.OFFSET CEMENT.T1 (PART # NR071Z-AS) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE CEMENTING PROCESS OF THE TIBIA TRAY AND STEM, THE CEMENT WORKED ITS WAY INTO THE TIBIA BASEPLATE. THE CEMENT ENTERED THE TIBIA TRAY AT THE JUNCTION OF THE INFERIOR SIDE OF TIBIA TRAY. THE CEMENT OBSTRUCTED THE THREADED SCREW HOLE FOR THE TIBIAL INSERT SCREW. REPORTEDLY, THE SURGEON SPENT EXTRA TIME REMOVING THE HARDENED CEMENT FROM THE SMALL SCREW HOLE BEFORE THE SCREW WAS ABLE TO BE PLACED. HOWEVER, THE SURGEON WAS ABLE TO CLEAR THE CEMENT AND INSERT THE SCREW. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506616 AS COLUMBUS REV F TIB.OFFSET CEMENT.T1 KNEE ENDOPROSTHETICS JWH AESCULAP AG NR071Z 52629268 04046963175948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention