BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC CONST LINER 58/70X32

    MDR report key: 1253026 · Received December 4, 2008

    Report

    Report Number
    1818910-2008-05729
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    P960054/S02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE KNOWN PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MFG DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION REGARDING THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS CEMENTED CONSTRAINED LINER WHICH PULLED OUT OF CAGE (CEMENT MFR UNK). OSTEOLYSIS WAS ALSO REPORTED, AS WELL AS THAT THE PT IS A CHRONIC DISLOCATOR, AND THAT THE DR REMOVED THE WELL-FIXED STEM FOR MORE ANTEVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC CONST LINER 58/70X32 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA WB6G31

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention