BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +9

    MDR report key: 3934846 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23407
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    August 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE METAL HEAD AND METAL LINER PROVIDED PRODUCT AND LOT COMBINATIONS IS NO LONGER REQUIRED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: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

    PATIENT WAS REVISED FOR HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413948 S-ROM M HEAD 36MM +9 HIP FEMORAL HEAD LPH DEPUY ORTHOPAEDICS, INC. 1818910 2569141

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention