BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS VEGA PS TIBIAL PLATEAU CEMENTED T2+

    MDR report key: 25052948 · Received April 30, 2026

    Report

    Report Number
    9610612-2026-00082
    Event Type
    Injury
    Date Received
    April 30, 2026
    Report Date
    May 11, 2026
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    PMA / PMN Number
    K101281
    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

    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 COMPONENT OF 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)). ASSOCIATED MEDWATCH REPORTS: UNKNOWN COMPONENT OF AESCULAP AG KNEE IMPLANT SYSTEM (AESCULAP AG INT. NO. (B)(4): 9610612-2026-00080). UNKNOWN COMPONENT OF AESCULAP AG KNEE IMPLANT SYSTEM (AESCULAP AG INT. NO. (B)(4): 9610612-2026-00081). UNKNOWN COMPONENT OF AESCULAP AG KNEE IMPLANT SYSTEM (AESCULAP AG INT. NO. (B)(4): 9610612-2026-00082). UNKNOWN COMPONENT OF AESCULAP AG KNEE IMPLANT SYSTEM (AESCULAP AG INT. NO. (B)(4): 9610612-2026-00033).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508317 AS VEGA PS TIBIAL PLATEAU CEMENTED T2+ KNEE ENDOPROSTHETICS JWH AESCULAP AG NX054Z 52645270

    Patients

    Seq Age Sex Outcome Treatment
    1