BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX60OD

    MDR report key: 2991101 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13243
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    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

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. IT WAS INDICATED THE DEVICES HAVE BEEN SENT FOR ANALYSIS. REVIEW OF PROVIDED PATIENT X-RAYS SHOWS EVIDENCE OF LUCENCY WITHIN ZONE VII AT THE CEMENT BONE INTERFACE ON THE LEFT SIDE WITH APPEARANCES THOUGHT TO REPRESENT EVIDENCE OF LOOSENING. CHANGES CONSISTENT WITH STRESS SHIELDING ARE ALSO NOTED IN THE GREATER TROCHANTER ON THIS SIDE. A SEARCH OF THE COMPLAINTS DATABASES FINDS TWO OTHER REPORTS AGAINST THE 2425485 LOT CODE. INVESTIGATION HAS FOUND THE TWO REPORTS ARE FOR THE SAME PATIENT AND FOR THE SAME DEVICE. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBER 121887460 LOT NUMBER 2424585 FOUND NO ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINDER OF THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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

    METALLOSIS FOUND INTER-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95815 PINNACLE MTL INS NEUT40IDX60OD METAL LINER KWA DEPUY ORTHOPAEDICS 2424585

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention