BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX56OD (DOI: 3/14/2006 - DOR 3/14/2008)

    MDR report key: 2876249 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-22975
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    March 14, 2008
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 11/19/2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND ATTACHED ELECTRONICALLY TO THE COMPLAINT. THE PATIENT WAS REVISED ON (B)(6) 2008 DUE TO PAIN. IT WAS NOTED THAT AN ACETABULAR FIXATION SCREW WAS PENETRATING THE INNER TABLE PRESUMABLY INTO THE ILIACUS MUSCLE POSSIBLY EXPLAINING THE SYMPTOMS. THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PAIN AND SUPERIOR INSTABILITY. THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN AND ACETABULAR LOOSENING. THE DEVICES WERE IDENTIFIED. PATIENT HEIGHT: (B)(6). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE CORRECTIVE ACTION WAS NOT ESTABLISHED. 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 COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT HAD HIP REPLACEMENT SURGERY ON (B)(6) 2006. SOMETIME IN 2007, PATIENT BEGAN TO EXPERIENCE PERSISTENT SHARP PAIN IN THE GROIN AREA. THIS PAIN PERSISTED AND IN 2008 PATIENT'S DOCTOR DECIDED HE NEEDED TO HAVE HIS HIP IMPLANT SURGICALLY REMOVED AND REPLACED. ON (B)(6) 2008, PATIENT UNDERWENT REVISION SURGERY. OVER TIME, PATIENT BEGAN TO EXPERIENCE PROGRESSIVE PAIN AND HIS DOCTOR DECIDED HE NEEDED TO HAVE HIS HIP IMPLANT SURGICALLY REMOVED AND REPLACED AGAIN. ON (B)(6) 2009, PATIENT UNDERWENT ANOTHER REVISION SURGERY. OVER TIME, PATIENT BEGAN EXPERIENCING A POPPING SENSATION IN HIS HIP ANTERIORLY AND PAIN POSTEROLATERALLY. PATIENTS DOCTOR DECIDED HE NEEDED TO HAVE HIS HIP IMPLANT SURGICALLY REMOVED AND REPLACED FOR A THIRD TIME. ON (B)(6) 2010, PATIENT UNDERWENT ANOTHER REVISION SURGERY. (B)(6). UPDATE: (B)(6) 2012 - PATIENT'S MEDICAL RECORDS WERE RECEIVED FROM LEGAL AND ATTACHED ELECTRONICALLY TO THE COMPLAINT. THE PATIENT WAS REVISED ON (B)(6) 2008 DUE TO PAIN. IT WAS NOTED THAT AN ACETABULAR FIXATION SCREW WAS PENETRATING THE INNER TABLE PRESUMABLY INTO THE ILIACUS MUSCLE POSSIBLY EXPLAINING THE SYMPTOMS. THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO PAIN AND SUPERIOR INSTABILITY. THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN AND ACETABULAR LOOSENING. THE DEVICES WERE IDENTIFIED. PATIENT HEIGHT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX56OD (DOI: 3/14/2006 - DOR 3/14/2008) TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. 1818910 2061468

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention