BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 1230225 · Received November 12, 2008

    Report

    Report Number
    1818910-2008-05031
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD THAT WOULD SUGGEST DEVICE ERROR. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS METAL ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA XYR34

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention