BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPONENT OF AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM

    MDR report key: 24454939 · Received February 26, 2026

    Report

    Report Number
    9610612-2026-00035
    Event Type
    Injury
    Date Received
    February 26, 2026
    Report Date
    April 29, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    OOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: DESCRIPTION UPDATED, B7: PATIENT HISTORY.

    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

    UPDATE: ADDITIONAL INFORMATION WAS PROVIDED INCLUDING OPERATIVE REPORTS FOR RIGHT TOTAL KNEE ARTHROPLASTY (TKA) AND RIGHT POLY SWAP. ASSOCIATED MEDWATCH REPORTS: UNKNOWN COMPONENT AESCULAP AG KNEE IMPLANT (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2026-00035), UNKNOWN COMPONENT AESCULAP AG KNEE IMPLANT (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00050), UNKNOWN COMPONENT AESCULAP AG KNEE IMPLANT (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00051), UNKNOWN COMPONENT AESCULAP AG KNEE IMPLANT (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00052), UNKNOWN COMPONENT AESCULAP AG KNEE IMPLANT (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00053).

    Description of Event or Problem · 0

    AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341058 COMPONENT OF AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM KNEE ENDOPROSTHETICS OOG AESCULAP AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention