BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SROM ACETABULAR CUP

    MDR report key: 2792578 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-23509
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    February 9, 2007
    Report Date
    September 21, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DIFFICULTY WALKING, AND REPEATED DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SROM ACETABULAR CUP ACETABULAR CUP KWA DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention