BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ C RM PMA

    MDR report key: 8028466 · Received November 1, 2018

    Report

    Report Number
    3002806535-2018-01175
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 3, 2018
    Report Date
    April 10, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    P010014
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. THE OBSERVED ON X-RAYS DEBRIS FROM OSTEOPHYTES, BONE OR BONE CEMENT MAY HAVE CONTRIBUTED TO THE PAIN REPORTED BY THE PATIENT. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM THIS FROM AVAILABLE INFORMATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT 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 DUE TO KNEE PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OXF ANAT BRG RT MD SIZE 3 PMA, ITEM 159575, LOT 930200, THERAPY DATE - (B)(6) 2018, OXF TWIN-PEG CMNTD FEM MD PMA, ITEM 161469, LOT 079850, 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: 3002806535-2018-01176 AND 3002806535-2018-01177.

    Description of Event or Problem · 1

    REVISION DUE TO KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867233 OXF UNI TIB TRAY SZ C RM PMA OXFORD CEMENTED TIBIAL TRAYS JWH BIOMET UK LTD. 132230

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R