BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SROM HIP LINER

    MDR report key: 2954830 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12061
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    April 16, 2007
    Report Date
    January 17, 2013
    Manufacturer
    DEPUY-RAYNHAM
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. MEDICAL RECORDS RECEIVED FROM LEGAL INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN AND POLY WEAR. DOI: APPROX. 18 YRS DOR: (B)(6)2007 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITHOUT DEVICE EXAMINATION. HOWEVER ALTHOUGH NOT RETURNED, IT WOULD NOT BE UNREASONABLE TO FIND POLY MATERIAL WEAR AFTER THE LENGTH OF TIME REPORTED AS IMPLANTED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED FROM LEGAL INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58835 UNKNOWN DEPUY SROM HIP LINER TOTAL HIP REPLACEMENT KWY DEPUY-RAYNHAM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention