BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL 12.0 MMA 8.0 FULL PC 12/14

    MDR report key: 1812662 · Received August 17, 2010

    Report

    Report Number
    1818910-2010-05400
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    November 12, 2009
    Report Date
    July 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953703
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAM OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE ROOT CAUSE FOR APPARENT MICROMOTION OF THE PROXIMAL REGION OF THE STEM APPEARS TO BE RELATED TO INADEQUATE FIXATION OF THE STEM IN THE PT'S FEMUR DUE TO INADEQUATE BONE SUPPORT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISION DUE TO FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOL 12.0 MMA 8.0 FULL PC 12/14 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA VK7H71

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention