BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS VEGA PS FEMORAL COMP.CEMENTED F6N R

    MDR report key: 16198981 · Received January 18, 2023

    Report

    Report Number
    9610612-2022-00393
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    July 20, 2021
    Report Date
    September 26, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    UDI-DI
    04046963810207
    PMA / PMN Number
    K101281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BECAUSE WE DID NOT RECEIVE ANY SAMPLE, A THOROUGH INVESTIGATION WAS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE 3 SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER 51873261 (INCLUDING THIS COMPLAINT). THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE. CONCLUSION AND PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION A CLEAR CONCLUSION REGARDING THE ROOT CAUSE CANNOT BE DRAWN. AT THIS TIME THERE ARE NO HINTS FOR A PRODUCT RELATED ERROR; IF PRODUCTS ARE RETURNED IN THE FUTURE, ANOTHER INVESTIGATION WILL BE PERFORMED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ASSOCIATED MEDWATCH-REPORTS: 400582818 (9610612-2022-00392) - NX055Z, 400582821 (9610612-2022-00393) - NX033Z. INVOLVED COMPONENTS: 400582819 - NX044 - PATELLA 3-PEGS P4 LOT 51849212. 400582820 - NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51901306. 400582822 - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51910799.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NX033Z - AS VEGA PS FEMORAL COMP.C. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS A GROSS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS OF THE RIGHT KNEE. THE PATELLAR COMPONENT WAS WELL FIXED. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE 100032169 (400582821). ASSOCIATED MEDWATCH-REPORTS: 400582818 (9610612-2022-00392) - NX055Z, 400582821 (9610612-2022-00393) - NX033Z. INVOLVED COMPONENTS: 400582819 - NX044 - PATELLA 3-PEGS P4 LOT 51849212, 400582820 - NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51901306, 400582822 - NN260P - PLUG F/TIBIAL PLATEAU - LOT 51910799.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977704 AS VEGA PS FEMORAL COMP.CEMENTED F6N R KNEE ENDOPROSTHETICS JWH AESCULAP AG NX033Z 51888840 04046963810207

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NN260P - LOT 51910799| NN260P - LOT 51910799| NX044 - LOT 51849212| NX044 - LOT 51849212| NX132 - LOT 51901306| NX132 - LOT 51901306