BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3013122 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14140
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 19, 2013
    Manufacturer
    DEPUY INTL., LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THESE DEVICES WERE REPORTED AS HAVING BEEN REVISED WHEN ADDRESSING THE FEMORAL FRACTURE AFTER THE PATIENT FALL / TRAUMA. THERE WAS NO ALLEGATION OF ANY ISSUE OR CONTRIBUTION REGARDING THESE DEVICES. BASED ON THE INVESTIGATION, 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

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS A METAL ON METAL HIP AND A PERIPROSTHETIC FRACTURE OF THE FEMUR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE STATING THE PATIENT FELL OFF A LADDER AND THE SUBSEQUENT XRAYS SHOWED A FRACTURE IN THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115048 PINNACLE MTL INS NEUT36IDX52OD LINER KWA DEPUY INTL., LTD. 8010379 3022492

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention