BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 2211886 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14353
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    May 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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. 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 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

    MEDWATCH USER FACILITY REPORT RECEIVED INDICATES THAT PT HAS BEEN EXPERIENCING PAIN. XRAYS INDICATE THAT THE LINER HAS SHIFTED IN THE CUP. PT HAS NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX54OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2775109

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention