BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 17886110 · Received October 6, 2023

    Report

    Report Number
    9610612-2023-00221
    Event Type
    Injury
    Date Received
    October 6, 2023
    Report Date
    November 29, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    OOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE INVESTIGATION WAS BASED UPON ANALYSIS OF HISTORICAL DATA REVIEW. 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. THE ASSESSMENT FOR REPORTABILILTY FOR THIS ADVERSE EVENT WAS BASED ON PATIENT HARM, PERMANENT IMPAIRMENT. CONCLUSION/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 INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

    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

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT AE-QAS-K521-56 - COLLECT.NO.QAS KNEE IMPLANTS VEGA. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SPECIFIC MEDICAL DEVICES AT ISSUE IN THIS COMPLAINT ARE AS FOLLOWS: VEGA SYSTEM 7-LAYER ADVANCED SURFACE COATING; VEGA SYSTEM FEMORAL COMPONENTS; VEGA SYSTEM TIBIAL COMPONENTS; AESCULAP IMPLANT SYSTEMS ADVANCED SURFACE TECHNOLOGY. THESE DESIGNS ARE DEFECTIVE AND HAVE FAILED, RESULTING IN HARM TO THE PLAINTIFF. THIS EVENT RESULTED IN A PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: AE-QAS-K521-56 - COLLECT.NO.QAS KNEE IMPLANTS VEGA - LOT UNKNOWN, AE-QAS-K521-56 - COLLECT.NO.QAS KNEE IMPLANTS VEGA - LOT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071960 COLLECT.NO.QAS KNEE IMPLANTS VEGA KNEE ENDOPROSTHETICS OOG AESCULAP AG AE-QAS-K521-56

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability AE-QAS-K521-56 - LOT UNKNOWN| AE-QAS-K521-56 - LOT UNKNOWN| AE-QAS-K521-56 - LOT UNKNOWN| AE-QAS-K521-56 - LOT UNKNOWN