BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AE-QAS-K521-99

    MDR report key: 24954874 · Received April 22, 2026

    Report

    Report Number
    3005673311-2026-00060
    Event Type
    Injury
    Date Received
    April 22, 2026
    Report Date
    April 22, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS ASSOCIATED WITH A LEFT TOTAL KNEE REPLACEMENT (TKR). ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT INITIALLY UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. FOLLOWING THE TOTAL KNEE REPLACEMENT, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS, INCLUDING PAIN, INSTABILITY, RECURRENT BUCKLING, AND LIMITED FUNCTION OF THE LEFT KNEE. AN OFFICE VISIT DATED (B)(6) 2023 DOCUMENTED 3+ EFFUSION AND LATERAL LAXITY, WITH CONCERN FOR INSTABILITY. DUE TO ONGOING SYMPTOMS, THE PATIENT UNDERWENT REVISION LEFT KNEE ARTHROPLASTY ON (B)(6) 2023. OPERATIVE FINDINGS INCLUDED LOOSENING OF THE TIBIAL COMPONENT WITH OBSERVED MICROMOTION. THE PROCEDURE INVOLVED REMOVAL OF THE LOOSENED COMPONENT AND IMPLANTATION OF A REVISED TIBIAL COMPONENT WITH POLYETHYLENE INSERT. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009775 AE-QAS-K521-99 KNEE ENDOPROSTHETICS JWH AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention