BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 6968000 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09487
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WALKER, T., STREIT, J., GOTTERBARM, T., BRUCKNER, T., MERLE, C., STREIT, M. (2015) SPORTS, PHYSICAL ACTIVITY AND PATIENT-REPORTED OUTCOMES AFTER MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY IN YOUNG PATIENTS. THE JOURNAL OF ARTHROPLASTY , VOLUME 30 , ISSUE 11 , 1911 ¿ 1916. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT DEVICE, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE PROVIDED. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "SPORTS, PHYSICAL ACTIVITY AND PATIENT-REPORTED OUTCOMES AFTER MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY IN YOUNG PATIENTS". THIS ARTICLE ADDRESSES THAT ONE (1) PATIENT HAD A BEARING EXCHANGE DUE TO THE IMPLANT FRACTURE 8 YEARS AFTER SURGERY. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749021 UNKNOWN KNEE PROSTHESIS - KNEE NRA ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R