MAUDE Adverse Event Report: SMITH & NEPHEW, INC.. SMITH AND NEPHEW LEGION KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTAINED, CEMENTED, POLYMER/METAL/

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Disability (2371); Test Result (2695); No Code Available (3191)

Event Date 02/13/2013

Event Type  Injury  

Event Description

I developed problems almost immediately after trk implant in 2013.Swelling, pain, redness, loss of motion to start but to date i've had 3 knees implanted.All of which has caused reactions that have now caused rashes, all over joint pain, fatigue that is incapacitating and a headache that refuses any medications and persistent nausea and stomach issues.I have had allergy testing, patch, melisa, and orthopedic analysis.They have shown me to be allergic to nickel, aluminum, chromium and zirconium.I've been seen by neurologists, ms, specialists, immunologist, had eegs, ekgs, mris, you name a test i've had it.It all has come back to the metal saturating my body.I had a career as a cardiac nurse but because of all this i've been forced to retire and go on disability.This has wrecked my life and now the worst part is that i have no options until a completely metal free knee is available.All knees currently on market contain at least one or more of these in some form or another.There are days i can barely walk because of the pain.I currently need a left knee as well as a right hip replacement but i cannot do it because of my allergy.Somethings needs to be done.It should be mandatory to have allergy testing before any joint replacement or the placement of any metal into a person.Had i known this have kept my bone on bone knee pain because at least then it would only be my leg hurting not my entire body.I have memory issues as well.I feel like i've forgotten half of all the things i spent years of my life learning.This has affected my whole family, my marriage, my friendships, my kids are afraid i'm going to die.I'm afraid i'm going to die.Please do something to help all of us whose lives have been ruined by metal allergies.It is sad when drs tell you that you are crazy and that there is no such thing as metal allergies.I'm here to say loudly that they do exist and they are slowly taking my life from me and from so many others just like me.Along with finding a metal free alternative there needs to be some kind of treatment to help lessen the painful debilitating symptoms that we deal with on a daily basis.I had 3rd knee implant aesculap (b)(6) 2014.After about 3 months, all problems started again and continue worsening to date.Sincerely, (b)(6).Fda safety report id#: (b)(4).

• Brand Name: SMITH AND NEPHEW LEGION KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTAINED, CEMENTED, POLYMER/METAL/
• Manufacturer (Section D): SMITH & NEPHEW, INC..
• MDR Report Key: 9197429
• MDR Text Key: 162707354
• Report Number: MW5090420
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/13/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 84