BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS

    MDR report key: 12044400 · Received June 22, 2021

    Report

    Report Number
    2916714-2021-00118
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    September 17, 2020
    Report Date
    September 15, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    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:DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. 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. A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    NO UPDATES.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-K521-53 - COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT UNDERWENT KNEE REVISION 1 YEAR 11 MONTH POST SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2018 (RIGHT KNEE) AND THE REVISION SURGERY OCCURRED ON (B)(6) 2020. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937021 COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS KNEE ENDOPROSTHESES JWH AESCULAP AG AE-QAS-K521-53

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention