BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY TIBIA COLUMBUS CR DD T1 10MM

    MDR report key: 11281230 · Received February 4, 2021

    Report

    Report Number
    9610612-2021-00048
    Event Type
    Injury
    Date Received
    February 4, 2021
    Report Date
    December 8, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JHW
    PMA / PMN Number
    K143443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6: CODES. 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: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. 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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NN1210-ALL POLY TIBIA COLUMBUS CR DD T1 10MM. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY AFTER THE PRIMARY SURGERY DUE TO PAIN AND INSTABILITY. THE 10 MM POLY INSERT WAS REPLACED WITH A 16 MM INSERT. AT THE END OF THE REVISION PROCEDURE, IT WAS NOTED THAT THE PATIENT WAS STABLE AND HAD SUITABLE FLEXION AND EXTENSION. AN ADDITIONAL INTERVENTION WAS REQUIRED. ALSO, THE PRODUCT WAS DISCARDED ON SITE AND THE OPERATIVE REPORT IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178599 ALL POLY TIBIA COLUMBUS CR DD T1 10MM KNEE ENDOPROSTHETICS JHW AESCULAP AG NN1210 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention