BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN

    MDR report key: 11422187 · Received March 5, 2021

    Report

    Report Number
    9610612-2021-00153
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    October 27, 2020
    Report Date
    September 21, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. 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. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PRODUCT CODE: NO CODE AVAILABLE, JWH WAS CHOSEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AE-QAS-K521-53 - COLLECT.NO. QAS KNEE IMPLANTS COLUMBUS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT CONTACTED UK OFFICE REQUESTING INFORMATION ON US SURGEONS FAMILIAR WITH AESCULAP KNEE PRODUCT. UK OFFICE TRANSFERRED PATIENT TO US OFFICE. PATIENT COMPLAINED ABOUT POSSIBLE ALLERGIC REACTION TO AESCULAP KNEE. HE HAS SWELLING AT THE CEMENTED AREA AND BURNING BELOW THE IMPLANT IN HIS LEG AFTER A YEAR. HE HAS TESTED POSITIVE FOR TITANIUM ALLERGY. HE ALSO STATED THAT HE WAS RECENTLY DIAGNOSED WITH THE IMPLANT LEG LENGTH SHORT BY 1. THE PATIENT HAS HAD A BONE STUDY PRIOR TO REVISION AND THE LEG WAS NORMAL IN LENGTH AT THAT POINT. IT WAS NOTED THAT HE HAD ALL METAL FILLINGS REMOVED IN THE LAST TWO MONTHS. A REVISION SURGERY IS POSSIBLY NECESSARY. THE PATIENT WILL FOLLOW-UP WITH A SURGEON AND RECEIVE TREATMENT BASED ON THE RECOMMENDATION. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316905 COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN KNEE ENDOPROSTHESES JWH AESCULAP AG AE-QAS-K521-99

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention