BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE GRIPTION

    MDR report key: 2120951 · Received June 3, 2011

    Report

    Report Number
    2120951
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    MALE PT WAS ADMITTED FOR REVISION OF A FAILED LEFT TOTAL HIP. THE ORIGINAL HIP WAS IMPLANTED SEVERAL YEARS AGO. THE PRODUCT WAS EVENTUALLY RECALLED BY THE DEPUY COMPANY. PT RECEIVED THE RECALL LETTER AND RETURNED (B)(6) FOR EXPLANTATION/REVISION OF HIS LEFT TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE GRIPTION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC LPH DEPUY ORTHOPAEDICS DP999890243 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR