BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2052859 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-06166
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    August 28, 2008
    Report Date
    March 8, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 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. 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.

    Description of Event or Problem · 1

    THE REVISION OPERATIVE REPORT STATES THE PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT ACETABULAR COMPONENT. OPERATIVE REPORT INDICATES THAT THE CUP HAD SLIPPED TO A VERTICAL POSITION FOLLOWING SURGERY. ADDITIONALLY THE PATIENT HAD A SIGNIFICANT REACTION IN THE JOINT WITH SOME WHITISH FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2436285

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention