BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD CEMENTLESS TIBIA C LM

    MDR report key: 7602665 · Received June 14, 2018

    Report

    Report Number
    3002806535-2018-00894
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 11, 2018
    Report Date
    November 12, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 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 · 0

    REVISION OF KNEE DUE TO PAIN AND INSTABILITY.

    Additional Manufacturer Narrative · 1

    UDI - (B)(4). MEDICAL PRODUCT - OXF TWIN PEG CMNTLS FMRL SM, ITEM 161473, LOT 3050579. THERAPY DATE - (B)(6) 2018. MEDICAL PRODUCT - OXF ANAT BRG LT SM SIZE 3 PMA, ITEM 159540, LOT 1076560. THERAPY DATE - (B)(6) 2018. 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: 3002806535-2018-00893 AND 3002806535-2018-00895.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REVISION OF KNEE DUE TO PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444343 OXFORD CEMENTLESS TIBIA C LM NRA BIOMET UK LTD. N/A R3050470A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R