BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 3841238 · Received May 30, 2014

    Report

    Report Number
    1818910-2014-19803
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    August 15, 2013
    Report Date
    August 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    ATTORNEY

    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. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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 DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    (B)(4). 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 METAL LINER LOT CODE WAS INCORRECTLY ENTERED, AND NOW HAS BEEN CORRECTLY ENTERED. A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE METAL LINER AND/OR FEMORAL HEAD PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER WI-3430. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE REMAINING PRODUCT CODE/LOT CODE COMBINATION(S). 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CORRECTED: NON-CONTRIBUTING: IMPLANT NOT REMOVED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AND METAL REACTION. UPDATE REC'D (B)(4) 2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, INFECTION, ELEVATED METAL ION LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD AND METALLOSIS. WE ARE ADDING THE CUP TO ADDRESS THE INFECTION ALLEGATIONS. THE COMPLAINT WAS UPDATED ON : (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319957 PINNACLE SECTOR II CUP 54MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US EY9KR1000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention