BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM SM PMA

    MDR report key: 8161850 · Received December 13, 2018

    Report

    Report Number
    3002806535-2018-01274
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 27, 2018
    Report Date
    April 11, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, STATING THAT THE REPORTED REVISION WAS PERFORMED DUE TO NATURAL DISEASE PROGRESSION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT WAS REVISED DUE TO UNKNOWN REASON.

    Description of Event or Problem · 0

    RIGHT KNEE REVISION DUE TO DISEASE PROGRESSION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - OXF UNI TIB TRAY SZ C RM PMA, ITEM: 154723, LOT: 192030; THERAPY DATE -(B)(6) 2018. CONCOMITANT MEDICAL PRODUCT - OXF ANAT BRG RT SM SIZE 4 PMA , ITEM: 159569, LOT: 206180; 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: 3002806535-2018-01275 AND 3002806535-2018-01276.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000744 OXF TWIN-PEG CMNTD FEM SM PMA UNKNOWN NRA BIOMET UK LTD. 566080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R