MAUDE Adverse Event Report: KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Rash (2033); Respiratory Tract Infection (2420); Low Oxygen Saturation (2477); Urinary Incontinence (4572)

Event Date 12/19/2018

Event Type  Injury  

Event Description

I went in and had knee replacement.Dr.(b)(6) knew i was allergic to nickel.He was assured that titanium was the way to go and he had done many surgeries with it.In (b)(6) 2019 i had surgery on my right knee.Again it was titanium and again we were told it was safe.In (b)(6) 2021 i had an upper respiratory infection as i had many times before.This time it put me in the hospital for 4 days.I was on oxygen and was discharged with oxygen; 3 years using a rolator and now oxygen.I could no longer leave and go about my life.(b)(6) 2021 i was assaulted and had an mri and x-rays i have to get those.Everything seemed fine again.In (b)(6) 2022 i started urinating on myself again.I couldn't make it to the bathroom and had to wear diapers.In (b)(6) 2022 i had a rash on my arm and my nails were breaking.I was being harassed with possibly having hiv(human immunodeficiency virus) so i looked it up and nail problems and rash is a common symptom.I finally got hiv(human immunodeficiency virus) test results in (b)(6) 2023 and i'm negative.In (b)(6) 2022 i was hospitalized 3× but in the er 4×.Lung problems causing my pulse oxygen to drop down to 77 with movement and again i was on oxygen and urinating on myself.The nurse was disgusted and brought in a bedside commode.In (b)(6) 2023 again in the hospital and again in (b)(6).In (b)(6) again urinating on myself even after using the restroom.(b)(6) i started having diarrhea on myself and again having a rash on my left arm.I have tasted metal and a dr at (b)(6) can tell you i had no pulse in my right wrist for a short time.In (b)(6) 2023 i was looking up titanium and i found out it has nickel.I'm not sure why you would think it's safe for someone who is allergic to it to have to be continuously exposed to it.I had an x-ray and asked dr mendelson why are my bones glowing like the knee replacements.He looked and talked with a colleague.Next i had an x-ray of both feet.Those looked fine except i have bone spurs on my left foot.They couldn't get blood out of my right arm.I've been freaking out since.I've realized i'm dying because you thought that if you expose someone who has an allergy to it that it wouldn't kill them slowly and painfully.They have nickel free sterling silver why would they have that if titanium was safe.Bilateral knee implant.Ref report: mw5118782.

• Brand Name: KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• MDR Report Key: 17199568
• MDR Text Key: 317944664
• Report Number: MW5118783
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White, American Indian Or Alaskan Native