BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2163695 · Received June 15, 2011

    Report

    Report Number
    1644408-2011-00339
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K961526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE CUP WAS LOOSE. ALL OF THE IMPLANTS WERE REMOVED EXCEPT THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP FLARED SHELL LPH ENCORE MEDICAL, L.P. 385261

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention 400-01-281, LOT 308481| 400-02-252, LOT 223831