BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 4121078 · Received September 26, 2014

    Report

    Report Number
    1818910-2014-28878
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 15, 2014
    Report Date
    January 6, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    UPDATE 1/6/15 - PFS AND MEDICAL RECORDS RECEIVED. A DOI WAS PROVIDED. THIS COMPLAINT IS NOW LEGAL AND ALLEGES PAIN, STIFFNESS, SWELLING, AND METALLOSIS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED METALLOSIS AND TRUNNIONOSIS. THE STEM IS NOW BEING ADDED TO THE COMPLAINT. LAB RESULTS FROM (B)(6) 2014 INDICATED THE METAL IONS LEVELS WERE BELOW 7PPB. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 2/3/2015.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600604 PINNACLE MTL INS NEUT36IDX58OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2178606

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention