BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3863609 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20553
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    INFORMATION RECEIVED FROM LIRC. REASON FOR REVISION NOT PROVIDED. ADDITIONAL INFORMATION REPORTS PATIENT ACTIVITY LEVEL IMPAIRED, RESTRICTED ROM, PAIN, CAN WALK 20 MINUTES WITHOUT PAIN. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE INSERT PRODUCT/LOT. PER PROCEDURE, THIS PRODUCT CODE IS EXEMPT FROM DHR REVIEW. NO OTHER REPORTS WERE FOUND AGAINST THE FEMORAL HEAD PRODUCT/LOT CODE. THE SEARCH WAS NOT POSSIBLE AGAINST THE CUP AS THE PRODUCT/LOT CODE WAS NOT PROVIDED. REASON FOR REVISION HAS NOT BEEN PROVIDED. THE INFORMATION IS INSUFFICIENT TO INVESTIGATE. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    REASON FOR REVISION NOT PROVIDED. ADDITIONAL INFORMATION REPORTS PATIENT ACTIVITY LEVEL IMPAIRED, RESTRICTED ROM, PAIN, CAN WALK 20 MINUTES WITHOUT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338094 PINNACLE MTL INS NEUT36IDX54OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD. REG. # 8010379 2132337

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention