BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3781486 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17784
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ACETABULAR AND FEMORAL POSITIONING CANNOT BE COMMENTED UPON AS NOT PATIENT X-RAYS WERE PROVIDED. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGIANST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND SUBLUXATION. LARGE PIECE OF TISSUE WAS REMOVED DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260209 PINNACLE MTL INS NEUT36IDX50OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTL., LTD. ¿ REG. # 8010379 2500895

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR