BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM MD PMA

    MDR report key: 7395173 · Received April 4, 2018

    Report

    Report Number
    3002806535-2018-00663
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    February 19, 2018
    Report Date
    August 20, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOGUE # 154727 OXF UNI TIB TRAY SZ E RM PMA LOT # 2964546, CATALOGUE # 159577 OXF ANAT BRG RT MD SIZE 5 PMA LOT # 2834022. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY, SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO BREAKAGE, LOOSENING AND PAIN. IT WAS REPORTED THAT THE TOP PEG OF THE FEMORAL COMPONENT WAS BROKEN SOMETIME AFTER IMPLANTATION AND PRIOR TO REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238841 OXF TWIN-PEG CMNTD FEM MD PMA PROSTHESIS, KNEE HRY BIOMET UK LTD. N/A 273610

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R