BEUDAMED
    FDA Adverse Event Other Summary report: N

    KEYSTONE HIP

    MDR report key: 2272466 · Received September 28, 2011

    Report

    Report Number
    1644408-2011-00526
    Event Type
    Other
    Date Received
    September 28, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K000521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE REMOVAL OF KEYSTONE STEM. THE STEM PERFORATED THE FEMORAL CANAL. ON (B)(6) 2011 A PHONE CONVERSATION WITH THE AGENCY REVEALED A DJO STEM WAS REMOVED AND A BIOMET STEM WAS IMPLANTED. THE ONLY DJO IMPLANTED USED AT THE REVISION WAS AN HXL LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KEYSTONE HIP REVISION BODY LPH ENCORE MEDICAL, L.P. 969881

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 490-00-000, LOT 53804013| 492-13-180, LOT 200172| 497-36-000, LOT 54002681| 932-36-256, LOT 53984018| 411-00-105, LOT 53912658