BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DEVICE

    MDR report key: 2961608 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-12388
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2356541 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH DID NOT FIND ANY OTHER COMPLAINTS AGAINST THE REMAINING PROVIDED PRODUCT AND LOT COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE UNKNOWN PRODUCTS AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM LOOSENING AND 'POPPING' SENSATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65725 UNKNOWN DEPUY DEVICE DEVICE KWY DEPUY INTL., LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other