BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED HIP IMPLANT OR INSTRUMENT

    MDR report key: 3133446 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-17675
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 17, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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 AT THIS TIME. SHOULD THE PRODUCT 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

    (B)(4) SUBMITTED BY PATIENT STATES THAT S/HE WAS REVISED TO ADDRESS SQUEAKING, CRACKING, AND POPPING, PAIN IN GROIN AND THIGH, AND HIGH COBALT CHROMIUM LEVELS. DURING THE REVISION, THE SURGEON WAS NOT ABLE TO REMOVE THE LINER FROM THE CUP AND ENDED UP HAVING TO REMOVE THE CUP. WHEN THE CUP WAS REMOVED, THE SURGEON FOUND DAMAGE TO THE PELVIS WITH PIECES OF METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237549 UNIDENTIFIED HIP IMPLANT OR INSTRUMENT ACETABULAR CUP KWA 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention