BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM HEAD FEMORAL COCR 28+0

    MDR report key: 1770248 · Received July 21, 2010

    Report

    Report Number
    1818910-2010-04661
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K920317
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. MINIMAL POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM HEAD FEMORAL COCR 28+0 87JDI JDI DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. NA 846441

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention