BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA UNI FEMORAL SZ 4

    MDR report key: 2232294 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15836
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K954481
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. 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.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA UNI FEMORAL SZ 4 87HRY HRY DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 229789

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention