BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 54MM

    MDR report key: 2111594 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08503
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    December 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF SUPPLIED OPERATIVE REPORTS CONFIRMED METALLOSIS. EXAMINATION OF SUPPLIED RADIOGRAPHS REVEALED POOR POSITIONING OF THE LINER AND CUP COMPONENTS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE POOR DEVICE POSITIONING. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN, OSTEOLYSIS, MALPOSITIONED CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 54MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA A81DW1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention