BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 4 PMA

    MDR report key: 7153786 · Received December 29, 2017

    Report

    Report Number
    3002806535-2017-01246
    Event Type
    Injury
    Date Received
    December 29, 2017
    Date of Event
    December 11, 2017
    Report Date
    March 26, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT - OXF TWIN-PEG CMNTD FEM MD PMA, ITEM 161469, LOT 160630 THERAPY DATE - (B)(6) 2017. MEDICAL PRODUCT - OXF UNI TIB TRAY SZ AA LM PMA, ITEM 159531, LOT 147840 THERAPY DATE -(B)(6) 2017. 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: 3002806535-2017-01223 AND 3002806535-2017-01247

    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 PROCEDURE AND SUBSEQUENTLY THE REVISION PROCEDURE WAS PERFORMED DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934289 OXF ANAT BRG LT MD SIZE 4 PMA KNEE PROTHESIS NRA BIOMET UK LTD. 198970

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R