BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SUMMIT TAPERED STEM SZ 4140 MM LGT 12/14

    MDR report key: 2961792 · Received February 11, 2013

    Report

    Report Number
    MW5028961
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    July 25, 2005
    Report Date
    January 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD A TOTAL RIGHT HIP REPLACEMENT ON (B)(6) 2005. SHE RECEIVED THE DEPUY ACETABULAR CUP 48 MM, DEPUY SUMMIT TAPERED STEM SZ 4 140 MM LGT 12/14, DEPUY ULTAMET LINER 28 MM, ARTICUL/EZE M 28 MM 1.5 DEP. PRIOR TO SURGERY, (B)(6) HAD A LONG HISTORY OF RIGHT HIP PAIN DUE ARTHRITIS SECONDARY TO DSYPLAGIA. ON (B)(6) 2005, (B)(6) REPORTED HAVING SOME GROIN PAIN AND WAS CONCERNED ABOUT LOOSENING. ON (B)(6) 2008, (B)(6) COMPLAINED ON PAIN IN THE BUTTOCKS. ON (B)(6) 2009, (B)(6) HAD COMPLAINTS OF RIGHT HIP PAIN AND A GRINDING NOISE AND SENSATION IN HER HIP. IN (B)(6) 2010, SHE RECEIVED A LETTER REGARDING RECALL OF A DEPUY METAL ON METAL PRODUCT. ON (B)(6) 2010, SHE COMPLAINED OF PAIN MOSTLY IN HER GROIN AND IN HER BUTTOCK. SUBSEQUENT TESTING REVEALED FLUID COLLECTION AROUND THE DEVICE AND MODERATELY ELEVATED LEVELS FOR COBALT AND CHROMIUM. ON (B)(6) 2010, (B)(6) HAD A RIGHT HIP DEPUY ARTHROPLASTY REVISION. SUBSEQUENTLY, (B)(6) HAS HAD PERSISTENT AND INCREASING PAIN IN HER RIGHT HIP. (B)(6) HAD REQUIRED INJECTIONS AND ORAL MEDICATIONS, INCLUDING DAILY HYDROCODONE, TO TRY TO MANAGE THIS PAIN WHICH CONTINUES AND IS BECOMING AN INCREASING PROBLEM. (B)(6) ALSO SUFFERS FROM DERMATOLOGIC PROBLEMS WITH RASHES ON HER SHOULDERS AND BACK WHICH HAD NEVER BEEN AN ISSUE PRIOR TO ELEVATIONS OF THE METALS. DATES OF USE: (B)(6) 2005 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: RIGHT HIP DEVELOPMENTAL DYSPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60046 DEPUY SUMMIT TAPERED STEM SZ 4140 MM LGT 12/14 HIP IMPLANT STEM LWJ DEPUY ORTHOPAEDICS, INC.
    60047 DEPUY ULTAMET LINER 28 MM HIP IMPLANT LINER KWA DEPUY ORTHOPAEDICS, INC.
    60048 ARTICULL EZE M 28 MM 1.5 DEP HIP IMPLANT JDI DEPUY ORTHOPAEDICS, INC.
    60148 DEPU PINNACLE ACETABULAR CUP SYSTEM HIP IMPLANT CUP KWA DEPUY ORTHOPAEDICS, INC. X4AD31000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R