BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3120768 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-17406
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 27, 2012
    Report Date
    May 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

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

    Additional Manufacturer Narrative · 1

    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(S) WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT.- PATIENT WAS REVISED TO ADDRESS A VERTICALLY POSITIONED CUP. UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN. A METAL LINER AND HEAD ARE NOW BEING REPORTED. DATE OF IMPLANT HAS ALSO BEEN IDENTIFIED.

    Description of Event or Problem · 1

    UPDATE 9/23/15- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. DATE OF BIRTH AND ATTORNEY INFORMATION ADDED, REVISION SURGERY ALSO REPORTED SQUEAKING, METALLOSIS, AND OSTEOLYSIS. METAL ION LABS PROVIDED AND ABOVE 7 PARTS PER BILLION. THE STEM IS BEING ADDED TO COMPLAINT NOW. PART UPDATED. THE COMPLAINT WAS UPDATED ON: OCT 19, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222895 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 2371747

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention