BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SROM 28MM L20D M138 LINER

    MDR report key: 2121207 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-09512
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 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, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT, INCLUDING A COMPETITOR MANUFACTURED FEMORAL HEAD. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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

    PT WAS REVISED TO ADDRESS DISLOCATION. IT WAS REPORTED THAT THE STEM, WHICH WAS A COMPETITOR'S PRODUCT, WAS ALSO LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SROM 28MM L20D M138 LINER TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention