BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 54OD

    MDR report key: 1972497 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-00440
    Event Type
    Injury
    Date Received
    January 26, 2011
    Report Date
    December 27, 2010
    Manufacturer
    DEPUY INTL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVISE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE: HOWEVER, THIS COMPLAINT IS PART OF A TREND UNDER INVESTIGATION AS PART OF (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    THE PT WAS REVISED DUE TO A PAIN. THA WAS DONE FOR THE LEFT HIP WITH MOM. AFTER THE SURGERY, THE PT SUFFERED FROM A PAIN IN THE LEFT HIP. IT WAS FOUND THAT THE TISSUE AROUND THE STEM NECK AND HEAD WAS BLACK. ALSO, BLACK FOREIGN MATTER LIKE ABRASION POWDER WAS FOUND BETWEEN THE HEAD AND NECK JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTAMET MTL INS NEUT 36MM 54OD 87KWA KWA DEPUY INTL, LTD. NA 2571747

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention