BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE

    MDR report key: 12910838 · Received December 1, 2021

    Report

    Report Number
    9610612-2021-00750
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    May 3, 2021
    Report Date
    January 25, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ARTICLE CODE WAS CHANGED FROM UNKNOWN (AESCULAP010) TO A COLLECTION NUMBER OF KNEE IMPLANTS - AE-QAS-K521-55. BUT THE SPECIFIC ITEM CODE IS STILL UNKNOWN (AS ENDURO).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AESCULAP010 - AESCULAP SURGICAL INSTRUMENTS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AS ENDURO KNEE (RIGHT KNEE) WAS REVISED DUE TO PAIN, SWELLING AND LOOSENING. THE AS ENDORO WAS ALLEGEDLY IMPLANTED ON (B)(6) 2019 AND REVISED ON (B)(6) 2021. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810385 COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHESES KRO AESCULAP AG AE-QAS-K521-55
    1810386 COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHESES KRO AESCULAP AG AE-QAS-K521-55

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention