BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIBIAL TRAY SZA LM/RL PMA

    MDR report key: 4102990 · Received September 19, 2014

    Report

    Report Number
    0001825034-2014-07774
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    March 10, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PK042093
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. DISCARDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT TO REMOVE "(B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO AN OVERSIZED TIBIAL TRAY WHICH COMPROMISED THE TIBIAL CEMENT MANTLE CAUSING IT TO FRACTURE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582146 OXFORD UNI TIBIAL TRAY SZA LM/RL PMA OXFORD PARTIAL KNEE HRY BIOMET UK LTD. N/A 2928113

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R