BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM CUP ACE, ZTT-1 L32,56DP

    MDR report key: 1000091 · Received February 18, 2008

    Report

    Report Number
    1818910-2008-00449
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    LPH
    PMA / PMN Number
    K951000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT AND LOT CODE SINCE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP, OSTEOLYSIS, AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM CUP ACE, ZTT-1 L32,56DP 87LPH LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA SA106702

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention