BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN

    MDR report key: 11219476 · Received January 22, 2021

    Report

    Report Number
    2916714-2020-00690
    Event Type
    Injury
    Date Received
    January 22, 2021
    Report Date
    January 22, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: REFERENCE CODE AE-QAS-K521-99, DEVICE NAME COLLECT.NO.QAS KNEE, IMPL.MISC./UNKNOWN, SERIAL NUMBER N/A, BATCH NUMBER UNKNOWN, UDI DEVICE IDENTIFIER N/A, UDI PRODUCTION IDENTIFIER UNKNOWN, BASIC UDI-DI N/A, UNIT OF USE UDI-DI N/A, MANUFACTURING DATE UNKNOWN. INVESTIGATION: NO AESCULAP ARTICLE NUMBER AND NO PRODUCT ARE AVAILABLE. THEREFORE A FAILURE DESCRIPTION AT THE PRODUCT IS NOT POSSIBLE. PICTORIAL DOCUMENTATION: NO AESCULAP ARTICLE NUMBER, NO PRODUCT AND NO PICTURES ARE AVAILABLE. 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. EXPLANATION AND RATIONALE: UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT ROOT CAUSE FOR THE MENTIONED DEVIATION. CORRECTIVE ACTION: FOR THE TOPIC (IMPLANT LOOSENING) A PRODUCT SAFETY CASE WAS INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-K521-99-COLLECT.NO.QAS KNEE IMPLANTS VEGA IT WAS REPORTED ON (B)(6) 2018, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED AN ISSUE WHICH IS UNKNOWN TO AESCULAP. THE PRIMARY SURGERY OCCURRED ON AN UNKNOWN DATE, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2013. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION 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
    114804 COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN KNEE ENDOPROSTHETICS JWH AESCULAP AG AE-QAS-K521-99

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention