BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 4 PMA

    MDR report key: 6947877 · Received October 13, 2017

    Report

    Report Number
    3002806535-2017-00943
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 13, 2017
    Report Date
    March 1, 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). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 3002806535-2017-00941, 3002806535-2017-00942. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 277325 STRYKER OP RCP 76.0X11.7 LOT 174879; 1506090 LOCKING SCREW PARTIALLY THREAD ED 5,0MMX9 LOT 904093; 159576 OXF ANAT BRG RT MD SIZE 4 PMA LOT 2115062; 154723 OXF UNI TIB TRAY SZ C RM PMA LOT 2070504; 154601 OXFORD UNI FEMORAL MD LOT 2169305.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. NO PATIENT CONSEQUENCES WERE REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728820 OXF ANAT BRG RT MD SIZE 4 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 2115062

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R