BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ C LM PMA

    MDR report key: 8304479 · Received February 5, 2019

    Report

    Report Number
    3002806535-2019-00084
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 7, 2019
    Report Date
    June 24, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ASSOCIATED PRODUCTS: MEDICAL PRODUCT:SAW BLADES STRYKER® SYSTEM 7, 6, 5, 4, 2000 & EHD ITEM NUMBER: 506298 LOT #: 278923 MEDICAL PRODUCT: OXF ANAT BRG LT MD SIZE 4 PMA ITEM NUMBER: 159548. LOT #: 878220 MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA ITEM NUMBER: 161469 LOT #: 502190 REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUBSIDED TIBIAL COMPONENT.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO SUBSIDED TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100760 OXF UNI TIB TRAY SZ C LM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 803650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R