BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS VEGA

    MDR report key: 15655108 · Received October 21, 2022

    Report

    Report Number
    9610612-2022-00295
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 23, 2022
    Report Date
    February 10, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE.UP TO NOW THERE ARE NO EXPLANTS AVAILABLE FOR INVESTIGATION. THE PROVIDED PICTURE SHOWED THAT THERE WAS NO CONNECTION/ADHESIVE BETWEEN BONE CEMENT AND IMPLANT AND NO CEMENT CONNECTION/ADHESIVE TO THE BONE. 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. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. EXPLANATION AND RATIONALE: ON THE BASIS OF THE CURRENT INFORMATION AND DUE TO THE CIRCUMSTANCE THAT WE DID NOT RECEIVE THE COMPLAINED DEVICES FOR INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE MENTIONED FAILURE. THERE ARE SEVERAL ROOT CAUSES FOR IMPLANT LOOSENING. ONE POSSIBLE ROOT CAUSE COULD BE THAT THERE WERE PROBLEMS WITH THE CEMENT TECHNIQUE AND DUE TO THIS THE IMPLANT HAS LOOSENED PREMATURELY. BUT IN THIS CASE THIS IS ONLY SPECULATIVE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. FOR THE TOPIC VEGA LOOSENING, PRODUCT SAFETY CASES (PSC) WERE INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH (B)(4)- COLLECT.NO.QAS KNEE IMPLANTS VEGA. ACCORDING TO THE COMPLAINT DESCRIPTION, THE VEGA DEVICES WERE REMOVED. THE ORIGINAL SURGERY WAS ABOUT FIVE (5) YEARS AGO. DURING REMOVAL, IT WAS NOTED THAT CEMENT NO LONGER ADHERED TO IMPLANTS NOR BONE; PICTURES WERE PROVIDED. REPLACEMENTS FOR THE IMPLANTS WERE MOST LIKELY NON-AESCULAP PRODUCTS. . A REVISION WAS REQUIRED DUE TO LOOSENING. ADDITIONAL DETAILS HAVE BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: (B)(4) (9610612-2022-00294) NX032Z, (B)(4) (9610612-2022-00295) AE-QAS-K521-56, (B)(4) (9610612-2022-00296) AE-QAS-K521-56.

    Description of Event or Problem · 0

    UPDATE: LEADING MATERIAL AE-QAS-K521-56 (400570913) CHANGED TO INVOLVED AFTER INVESTIGATION. ASSOCIATED MEDWATCH REPORTS: 400570906 (9610612-2022-00294) NX032Z, 400570912 (9610612-2022-00295) AE-QAS-K521-56. INVOLVED COMPONENT: 400570913 (9610612-2022-00296) AE-QAS-K521-56.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648493 COLLECT.NO.QAS KNEE IMPLANTS VEGA KNEE ENDOPROSTHESES JWH AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention AE-QAS-K521-56