BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 2810028 · Received October 31, 2012

    Report

    Report Number
    1818910-2012-26526
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 9, 2012
    Report Date
    October 3, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. PER THE REPORTING PATIENT X-RAYS ARE NOT AVAILABLE FOR EXAMINATION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS STEM LOOSENING. UPDATE: (B)(6) 2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO LOOSENING, PAIN AND DISCOMFORT ARE ALLEGED. A METAL LINER AND FEMORAL HEAD HAVE BEEN ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 1034398

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention