BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX520D

    MDR report key: 2833200 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-26456
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH 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 IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATE - (B)(4) 2012 - THE COMPLAINT IS BEING UPDATED WITH PART AND LOT INFORMATION FOR THE PATIENTS LEFT HIP, WHICH WAS REVISED ON (B)(6) 2012 AT THE PATIENTS REQUEST. THE COMPLAINT HAS BEEN CHANGED TO TIER 2. NOTE: THE REPORT RECEIVED FROM THE SALES REP STATES THAT THE DOI FOR THE LEFT HIP IS (B)(6) 2010, RATHER THAN (B)(6) 2009, AS STATED ABOVE. IT IS NOT KNOWN WHICH DOI IS THE CORRECT ONE. 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. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT DESCRIPTION, BRAND NAME, TYPE OF DEVICE, EXPLANT DATE, REPORT SOURCE. ADDED: AGE, WEIGHT, 510K#, DEVICE MFR DATE. 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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 ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, LOOSENING, AND METALLOSIS AMONG OTHER INJURIES. BILATERAL DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (RIGHT SIDE). DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(4) 2012 - THE COMPLAINT IS BEING UPDATED WITH PART AND LOT INFORMATION FOR THE PATIENTS LEFT HIP, WHICH WAS REVISED ON (B)(6) 2012 AT THE PATIENTS REQUEST. THE COMPLAINT HAS BEEN CHANGED TO TIER 2. NOTE: THE REPORT RECEIVED FROM THE SALES REP STATES THAT THE DOI FOR THE LEFT HIP IS (B)(6) 2010, RATHER THAN (B)(6) 2009, AS STATED ABOVE. IT IS NOT KNOWN WHICH DOI IS THE CORRECT ONE.

    Description of Event or Problem · 1

    UPDATE 02/06/2017 ¿PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, MEDICAL RECORDS FROM (B)(6) 2009 REPORT THAT THE PATIENT HAS ¿FALLEN A COUPLE TIMES¿, RADIOGRAPHS ARE REPORTED TO SHOW THE FEMORAL COMPONENT HAS SUBSIDED 1.5 CM WITH NO VISIBLE FRACTURE. THE MEDICAL RECORDS WENT ON TO STATE THAT THE SUBSIDENCE WAS DUE TO ¿PROBABLE OSTEOPOROSIS¿. THE REVISION NOTES REPORT THE FEMORAL STEM HAD SUBSIDED AND WAS LOOSE AND THE ACETABULAR CUP HAD ¿MIGRATED¿. ALL COMPONENTS REVISED. UPDATING LOT INFORMATION ON LINER, CHANGING UNKNOWN PRODUCT TO STEM, AND ADDING CUP AND THREE SCREWS FOR MIGRATION. THE COMPLAINT WAS UPDATED ON: 02/22/2017.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, LOOSENING, AND METALLOSIS AMONG OTHER INJURIES.BILATERAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX520D ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC US 2706659

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention ARTICULEZE M HEAD 36MM +5| PINN CAN BONE SCREW 6.5MMX20MM| PINN CAN BONE SCREW 6.5MMX25MM| PINN CAN BONE SCREW 6.5MMX30MM| PINNACLE SECTOR II CUP 52MM| SUMMIT POR TAPER SZ2 STD OFF