BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 6968038 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09531
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 22, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    KORT, N. P., JOS J. A. M. VAN RAAY, & HORN, J. J. (2006). THE OXFORD PHASE III UNICOMPARTMENTAL KNEE REPLACEMENT IN PATIENTS LESS THAN 60 YEARS OF AGE. KNEE SURGERY, SPORTS TRAUMATOLOGY, ARTHROSCOPY, 15(4), 356-360. DOI:10.1007/S00167-006-0204-9. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, 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

    A NON-OBESE PATIENT WAS IDENTIFIED IN THE ARTICLE THAT HAD MALALIGNMENT OF THE FEMORAL COMPONENT ON AN UNKNOWN DATE AFTER UNDERGOING A UNICOMPARTMENTAL KNEE ARTHROPLASTY. THE PATIENT HAD NO COMPLAINTS AND NEEDED NO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749458 UNKNOWN OXFORD KNEE PROSTHESIS - KNEE NRA ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other