BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANATOMIC BRG RT LG SIZE 3 PMA

    MDR report key: 6979624 · Received October 26, 2017

    Report

    Report Number
    3002806535-2017-00973
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 26, 2017
    Report Date
    February 23, 2018
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535 - 2017 - 00973, 3002806535 - 2017 - 00974, 3002806535 - 2017 - 00975. UDI - (B)(4). CONCOMITANT PRODUCT(S): A 159582 OXF ANAT BRG RT LG SIZE 3 PMA 390890. A 161470 OXF TWIN-PEG CMNTD FEM LG PMA 750990. A 154723 OXF UNI TIB TRAY SZ C RM PMA 997500. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT WAS REVISED TO ADDRESS PAIN. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758637 OXFORD ANATOMIC BRG RT LG SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 390890

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R