BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8/15.0 L LRG STAT

    MDR report key: 3180451 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19410
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    October 13, 2008
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK030979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. THE PATIENT WAS REVISED BECAUSE OF A LOOSE FEMORAL STEM.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF CUP AND BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280834 SOL SYS 8/15.0 L LRG STAT FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US AS4H31000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention