BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 4190482 · Received October 21, 2014

    Report

    Report Number
    1818910-2014-30346
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    January 10, 2015
    Manufacturer
    DEPUY INTL., LTD.8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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

    (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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. MEDICAL RECORDS AND X-RAY(S) WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. WITH THE INFORMATION PROVIDED, IT IS DETERMINED THE PATIENT HAD AN ADVERSE LOCAL TISSUE REACTION RELATED TO THE METAL ON METAL IMPLANTS WITH ELEVATED METAL ION LEVELS. 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.

    Description of Event or Problem · 1

    THE PATIENT'S MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. RECORDS INDICATED THAT UPON REVISION THE PATIENT WAS FOUND TO HAVE A LARGE PSEUDOTUMOR THAT WAS FULL OF BEIGE COLORED FLUID. RECORDS ALSO CONFIRMED THE PATIENT'S METAL IONS TO BE HIGH. THE PATIENT'S HEAD AND LINER ARE BEING REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    UPDATE RECEIVED 1/10/15. CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO ADDRESS ELEVATED COBALT LEVELS. UPDATE RECEIVED 1/12/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666922 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTL., LTD.8010379 2471649

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention