BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ6 HI OFF

    MDR report key: 3082059 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-16166
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 12, 2013
    Report Date
    November 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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 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. 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.

    Description of Event or Problem · 1

    CLAIM RECEIVED. PATIENT ALLEGES THAT HE SUFFERS FROM PAIN, CLICKS/POPS, AND ELEVATED METAL IONS. **UPDATE: 4/16/2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THAT THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, AND/OR LOOSENED INHIBITING PATIENT'S ABILITY TO WALK. DATE OF IMPLANT, DATE OF REVISION AND SIDE HAVE BEEN IDENTIFIED. AN UNKNOWN CUP HAS BEEN ADDED TO ADDRESS THE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183688 SUMMIT DUOFIX TAP SZ6 HI OFF HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US A2DFN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention