BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX58OD

    MDR report key: 7279760 · Received February 19, 2018

    Report

    Report Number
    1818910-2018-53580
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    January 13, 2017
    Report Date
    January 26, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    UPDATE AD (B)(6) 2018: PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES PAIN,DISCOMFORT,AND ABNORMALLY HIGH LEVELS OF COBALT AND CHROMIUM. LITIGATION STATED THAT THERE IS A RIGHT HIP REVISION ON (B)(6) 2017 , HOWEVER IT DID NOT MENTION THAT THE PATIENT IS BILATERAL. SHALL THERE BE NEW INFORMATION RECEIVED, THIS COMPLAINT WILL BE UPDATED AND ANOTHER COMPLAINT WILL BE CREATED AS NECESSARY. DOI: (B)96) 2009 -DOR: NOT REPORTED (LEFT HIP).

    Description of Event or Problem · 1

    PINNACLE PPF AND IMPLANT STICKER RECEIVED. PPF ALLEGES BONE FRACTURE, LOOSENING OF STEM, METAL WEAR AND METALLOSIS CONFIRMED IN MEDICAL RECORDS. PPF STATED THAT THE LINER , HEAD AND STEM WAS THE ONLY REVISED PRODUCTS. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123588 PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY INTERNATIONAL LTD. 8010379 2909958

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention