BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHELL ACET ASR SZ 58

    MDR report key: 2028386 · Received March 18, 2011

    Report

    Report Number
    MW5019898
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6) MALE WITH A HISTORY OF A DEPUY ASR LEFT HIP SYSTEM IMPLANTED ON (B)(6) 2008. ON (B)(6) 2010, PRESENTED WITH NEW ONSET AND PAIN IN THE LEFT HIP (10 DAYS), SWELLING IN THE LEFT BUTTOCK AND FEVERS AS HIGH AS 102 DEGREES. ON (B)(6) 2010, INFECTED LEFT TOTAL HIP ARTHROPLASTY, LEFT GLUTEAL ABSCESS INCISION AND DRAINAGE (I&D). ON (B)(6) 2011, I&D FOLLOW-UP. PRESENTED WITH SCANL PAIN, DRAINAGE. WISHES TO PURSUE A REVISION TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELL ACET ASR SZ 58 DEPUY ASR HIP SYSTEM KWA DEPUY ORTHOPAEDICS, INC. 999800758 2590170
    2 COMPONENT FEM UNI ASR SZ 51 DEPUY ASR HIP SYSTEM KWA DEPUY ORTHOPAEDICS, INC. 999890251 62542
    3 ADAPTOR SLEEVE ASR 12/14 +2 TAPER DEPUY ASR HIP SYSTEM KWA DEPUY ORTHOPAEDICS, INC. 999800312 2585493

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other