BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT MD SIZE 3 PMA

    MDR report key: 8096559 · Received November 21, 2018

    Report

    Report Number
    3002806535-2018-01202
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 23, 2018
    Report Date
    April 29, 2019
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. TIBIAL COMPONENT AND BEARING WERE REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: OXF UNI CMNTLS TIB SZ A LM, ITEM 166845, LOT 6060390. THERAPY DATE: (B)(6) 2018. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). 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 REPORT: 3002806535-2018-01201.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. TIBIAL COMPONENT AND BEARING WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934393 OXF ANAT BRG LT MD SIZE 3 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. 6193792

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R