BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVATION UNI FEM CEM SZ3

    MDR report key: 2034053 · Received March 24, 2011

    Report

    Report Number
    1818910-2011-04842
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSE FEMORAL COMPONENT AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESERVATION UNI FEM CEM SZ3 87HRY HRY DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS NA 2481813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention