BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS COLUMBUS REV FEM.SPACER POST.F7 5MM

    MDR report key: 14877308 · Received June 30, 2022

    Report

    Report Number
    9610612-2022-00178
    Event Type
    Injury
    Date Received
    June 30, 2022
    Report Date
    July 20, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    JWI
    PMA / PMN Number
    K083772
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INSPECTION: IN THE CLOSED STERILE PACKAGES THE SCREW IS NO MORE FIXED IN THE SPACER AS INTENDED. AS A RESULT OF THIS, SMALLEST METAL PARTICLES COME LOOSE AND MAKE THE PRODUCT UNUSABLE. BATCH HISTORY REVIEW THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: THE IMPLANTS ITSELF WILL BE REVIEWED BY 100 PER CENT VISUAL INSPECTION WITHIN THE PRODUCTION- AND PACKAGING PROCESS. THEREFORE IT IS UNLIKELY THAT THE DEVICE HAS LEFT AAG IN SUCH CONDITION (SCREW NOT FIXED IN THE SPACER). IT COULD BE POSSIBLE THAT RELATIVE MOVEMENT (DURING TRANSPORTATION) COULD CAUSE THE SCREW TO LOOSEN AND UNSCREW. MOVEMENT IS ALWAYS POSSIBLE WHEN EVACUATING THE PACKAGING. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. BASED UPON THE INVESTIGATIONS RESULTS, A PRODUCT SAFETY CASE (PSC) HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NR567Z - AS COLUMBUS REV FEM.SPACER POST.F7 5MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SPACER WAS NOT IMPLANTED. DARKENED COLOR OF THE IMPLANT HAD BEEN NOTED. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A BIGGER SIZE WAS USED INSTEAD AND FEMUR CUT ACCORDINGLY. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028728 AS COLUMBUS REV FEM.SPACER POST.F7 5MM KNEE ENDOPROSTHESES JWI AESCULAP AG NR567Z 52216850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention