BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ E RM PMA

    MDR report key: 7216125 · Received January 24, 2018

    Report

    Report Number
    3002806535-2018-00169
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    December 20, 2011
    Report Date
    April 10, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - OXF ANAT BRG RT LG SIZE 3 PMA, ITEM 159582, LOT 1964426, THERAPY DATE - (B)(6) 2011. CONCOMITANT MEDICAL PRODUCT - OXFORD UNI TWIN-PEG FEMORAL LG, ITEM 166943, LOT 2204368, THERAPY DATE - (B)(6) 2011. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-00167 AND 3002806535-2018-00168.

    Description of Event or Problem · 1

    IT WAS REPORTED REVISION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59451 OXF UNI TIB TRAY SZ E RM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 2113076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R