BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 15503825 · Received September 29, 2022

    Report

    Report Number
    9610612-2022-00279
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 4, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    OOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 WERE 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. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL AGAIN BE COMPLETED AT THAT TIME. REGARDING VEGA IMPLANT LOOSENING, PRODUCT SAFETY CASES (PSCS) WERE "INITIATED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN UNSPECIFIED VEGA IMPLANT (AE-QAS-K521-56). ACCORDING TO THE COMPLAINT DESCRIPTION, THE KNEE IMPLANT(S) LOOSENED APPROXIMATELY FIVE YEARS POSTOPERATIVELY. A TOTAL KNEE REVISION WAS REQUIRED DUE TO IMPLANT LOOSENING. WHEN THE TIBIA AND FEMUR IMPLANTS WERE REMOVED, THEY EASILY BACKED OUT AND HAD NO CEMENT RESIDUES. THE PATIENT WAS REVISED TO A COLUMBUS KNEE SYSTEM. THE PATIENT WAS NOTED TO BE STABLE AFTER THE PROCEDURE AND WITHOUT COMPLICATIONS. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2022-00279) AE-QAS-K521-56. (B)(4) (9610612-2022-00291) AE-QAS-K521-56. (B)(4) (9610612-2022-00292) AE-QAS-K521-56.

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2022-00279) AE-QAS-K521-56, (B)(4) (9610612-2022-00291) AE-QAS-K521-56, AND (B)(4) (9610612-2022-00292) AE-QAS-K521-56.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766822 COLLECT.NO.QAS KNEE IMPLANTS VEGA KNEE ENDOPROSTHETICS OOG AESCULAP AG AE-QAS-K521-56

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention