BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM LG PMA

    MDR report key: 8653580 · Received May 30, 2019

    Report

    Report Number
    3002806535-2019-00473
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    September 4, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ D RM PMA CATALOG #: 154725 LOT #: 2971276, MEDICAL PRODUCT: OXF ANAT BRG RT LG SIZE 3 PMA CATALOG #: 159582 LOT #: 2958726. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNK OXFORD TIBIAL COMPONENT, CATALOG #: UNK, LOT #: UNK, MEDICAL PRODUCT: UNK OXFORD BEARING, CATALOG #: UNK, LOT #: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00474, 3002806535-2019-00475. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446265 OXF TWIN-PEG CMNTD FEM LG PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2992011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R