BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS FEM TO SLEEVE ADAPTER +0

    MDR report key: 2822277 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-26749
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    August 10, 2012
    Report Date
    February 15, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    JWH
    PMA / PMN Number
    K063633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING NEW PART/LOT INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. 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, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED FOR EVALUATION. EXAMINATION OF SUPPLIED MEDICAL RECORDS SUGGESTS DEVICE LOOSENING IN VIVO. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED LOOSENING. 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, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED FOR ASEPTIC LOOSENING OF THE FEMUR (RIGHT KNEE).

    Description of Event or Problem · 1

    UPDATE: 2/15/2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION, BUT PART/LOT INFORMATION WAS UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPS FEM TO SLEEVE ADAPTER +0 FEMORAL JWH DEPUY WARSAW ES1HN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention