BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS

    MDR report key: 21268630 · Received January 29, 2025

    Report

    Report Number
    3005673311-2025-00002
    Event Type
    Injury
    Date Received
    January 29, 2025
    Report Date
    February 28, 2025
    Manufacturer
    AESCULAP AG
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER 400694293. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF COLUMBUS KNEE IMPLANTS. ACCORDING TO THE COMPLAINT DESCRIPTION, A POLY SWAP HAD BEEN PLANNED FOR (B)(6) 2025 BUT DID NOT OCCUR. HOWEVER, A REVISION TO A NON-AESCULAP IMPLANT SYSTEM WAS PROBABLE. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759388 COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS KNEE ENDOPROSTHETICS JWH AESCULAP AG AE-QAS-K521-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention