BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD CEMENTLESS TIBIA B LM

    MDR report key: 7649641 · Received June 29, 2018

    Report

    Report Number
    3002806535-2018-00927
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    June 7, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS, ITEM 161474, LOT R2494936A, THERAPY DATE - DEVICE REMAINS IMPLANTED, OXF ANAT BRG LT MD SIZE 3 PMA , ITEM 159547, LOT 644680, THERAPY DATE - DEVICE REMAINS IMPLANTED. 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: 3002806535-2018-00925 AND 3002806535-2018-000926

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDER WENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT REPORTED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493501 OXFORD CEMENTLESS TIBIA B LM HRY BIOMET UK LTD. N/A R3050461A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR