BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS VEGA SYSTEM® PS

    MDR report key: 24584061 · Received March 12, 2026

    Report

    Report Number
    3005673311-2026-00005
    Event Type
    Injury
    Date Received
    March 12, 2026
    Report Date
    April 27, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    UDI-DI
    04046963809904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP INC. REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639465 AS VEGA SYSTEM® PS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH AESCULAP AG NX011Z 52585239 04046963809904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention