BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 60MM

    MDR report key: 3071185 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-15663
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 SEEKING LEGAL ACTION. PFS RECEIVED. (B)(6) 2013, SALES REP REPORTS THAT THE PATIENT WAS REVISED BECAUSE OF METAL SENSITIVITY. (B)(6) 2013 - CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS ALVAL. RADIOGRAPHIC EVALUATIONS INDICATE THE CUP WAS ANTEVERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171996 PINNACLE 100 ACET CUP 60MM CUP LPH DEPUY ORTHOPAEDICS INC US Y23CV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention