BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 52MM

    MDR report key: 1772344 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-05350
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN, SQUEAKING, AND HIGH LEVEL OF METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 52MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA ZK2EN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention