BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 3 PMA

    MDR report key: 6970050 · Received October 23, 2017

    Report

    Report Number
    3002806535-2017-00960
    Event Type
    Injury
    Date Received
    October 23, 2017
    Date of Event
    March 22, 2016
    Report Date
    October 18, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 00959, 3002806535 - 2017 - 00960, 3002806535 - 2017 - 00961. UDI - (B)(4). CONCOMITANT PRODUCT(S): A 161470 OXF TWIN-PEG CMNTD FEM LG PMA 2234858. A 159582 OXF ANAT BRG RT LG SIZE 3 PMA 968810. A 154727 OXF UNI TIB TRAY SZ E RM PMA 2379351. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. HOWEVER, REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE PRESENCE OF A UNKNOWN THIRD BODY THAT MAY BE A CONTRIBUTING FACTOR TO THE PATIENT'S REPORTED PAIN. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CLINICAL STUDY A PATIENT EXPERIENCED PERSISTENT PAIN. THE OUTCOME REPORTED WAS PAIN TOLERATED BY PATIENT. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749988 OXF ANAT BRG RT LG SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 968810

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other