BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM

    MDR report key: 24559460 · Received March 10, 2026

    Report

    Report Number
    9610612-2026-00040
    Event Type
    Injury
    Date Received
    March 10, 2026
    Report Date
    April 7, 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

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. D10 - INVOLVED COMPONENTS. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED MEDICAL DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON EVENT DESCRIPTION AND REVIEW OF PICTURES. THE PROVIDED PICTURES DID NOT PROVIDE FURTHER INFORMATION. DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. ALSO, AFTER MEANINGFUL ATTEMPTS NO FURTHER INFORMATION COULD BE RECEIVED. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE IMPLANT LOOSENING COULD NOT BE DETERMINED. IN THE EVENT THAT THE COMPLAINED DEVICE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED. FINAL COMMENTS: 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.

    Description of Event or Problem · 0

    AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS POSTOPERATIVE LOOSENING. A REVISION SURGERY HAD BEEN PLANNED. THIS IS IN REFERENCE TO THE LEFT KNEE. 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: NX211 (AESCULAP AG REFERENCE NO. (B)(4) UNKNOWN COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM (AESCULAP AG REFERENCE NO. (B)(4) UNKNOWN COMPONENT AESCULAP AG KNEE VEGA IMPLANT SYSTEM (AESCULAP AG REFERENCE NO. (B)(4).

    Description of Event or Problem · 0

    UPDATE: THIS MEDICAL DEVICE IS NOW CONSIDERED TO BE AN INVOLVED COMPONENT. ASSOCIATED MEDWATCH REPORTS: NX051Z (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00032). UNKNOWN COMPONENT AESCULAP AG KNEE VEGA IMPLANT SYSTEM (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00041). INVOLVED COMPONENTS: NX211/ VEGA PS+ GLIDING SURFACE T1/1+ 12MM (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2026-00040). UNKNOWN COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM (AESCULAP AG REFERENCE NO. (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504384 UNKNOWN COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM KNEE ENDOPROSTHETICS OOG AESCULAP AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NX211 - LOT 52537213.| UNK COMPONENT AESCULAP AG VEGA KNEE IMPLANT SYSTEM.