BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 3103196 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16857
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PATIENT SEEKING LEGAL ACTION.

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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.

    Description of Event or Problem · 1

    LEGAL CLAIM RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND ELEVATED LEVELS OF COBALT CHROMIUM.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, LITIGATION ALLEGES THAT THE CORROSION AND FRICTION WEAR CAUSED TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE PLAINTIFF'S TISSUE SURROUNDING THE IMPLANT. DOI: (B)(6) 2010 - DOR: (B)(6) 2015 (LEFT HIP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203284 PINNACLE MTL INS NEUT40IDX56OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2763085

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 12/14 ARTICUL 40MM M SPEC+8.5| APEX HOLE ELIM POSITIVE STOP| PINNACLE 100 ACET CUP 56MM| SUMMIT POR TAPER SZ7 STD OFF