BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY SROM STEM

    MDR report key: 2113188 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-07846
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVISE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVISE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. REPEATED ATTEMPTS TO OBTAIN THE COMPLAINT SAMPLES PROVED UNSUCCESSFUL. IT WAS NOTED THAT THE PRODUCT CATALOGUE NUMBER, BATCH AND LOT NUMBERS ARE NOT AVAILABLE AS THE PRIMARY HIP WAS PERFORMED APPROXIMATELY 18 YEARS AGO. EXPLANTS WERE DISCARDED. 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.

    Additional Manufacturer Narrative · 1

    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 TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY SROM STEM TOTAL HIP PROSTHESIS KWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention