BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8IN CALC 15.0MM

    MDR report key: 3201933 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20387
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 18, 2012
    Report Date
    June 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS 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.

    Description of Event or Problem · 1

    UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, ADDITIONAL OPERATIVE NOTES INDICATED THAT THE PATIENT SUFFERED FROM PAIN AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301463 SOL SYS 8IN CALC 15.0MM FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. E5EB41000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention