BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX64OD

    MDR report key: 4820941 · Received June 5, 2015

    Report

    Report Number
    1818910-2015-22792
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    November 27, 2012
    Report Date
    May 8, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PPD ALLEGES THE PATIENT WAS REVISED FOR INFECTION. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATES THE PATIENT THE PATIENT WAS REVISED FOR EITHER INFECTION OR METALLOSIS. THE NOTE CONFIRMS METALLOSIS, BUT DOESN¿T CONFIRM INFECTION. ALL IMPLANTS WERE STILL REMOVED AND SPACERS WERE PLACED.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364197 PINNACLE MTL INS NEUT44IDX64OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 2383563

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention