BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 3665196 · Received March 6, 2014

    Report

    Report Number
    1818910-2014-13784
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    December 6, 2011
    Report Date
    February 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 1191263 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATION OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR 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. 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

    (B)(4).

    Description of Event or Problem · 1

    PFS WITH PRIMARY AND REVISION MEDICAL RECORDS RECEIVED. THE PATIENT WAS REVISED BECAUSE OF INFECTION.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134883 PINNACLE MTL INS NEUT36IDX58OD HIP ACETABULAR LINER KWA DEPUY ORTHOPAEDICS INC US 1191263

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention