MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY (ATTUNE KNEE SYSTEM); PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Nonstandard Device (1420)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 11/27/2017

Event Type  Injury  

Event Description

I had a bilateral joint replacement surgery on (b)(6) 2017 due to severe osteoarthritis in both knees.My doctor/surgeon suggested that i have them both done at the same time.The surgeon implanted the depuy (attune knee system).I was 54 years old at the time of surgery.The next day up until this day.I am having such issues as difficulty walking, standing, even limping on the left knee.The implant is worse at night with intense stiffness, that it is hard for me to sleep or get out of bed.I have complained about my left knee in physical therapy/hospital rehab.I have lost range of motion in my left knee.I cannot even use a stationary bike.I have to do my household chores slow, and sit because i get tired easily.I also began to search out other orthopedic doctors to get answers.I did contact my old ortho doctor's office to request a report of my surgery.I have found out that depuy had recalled their system.I know i have a defective device, because of all of the problems i am having.This is really shameful of the doctors who should have informed their patients that there was a recall.I now have to have revision surgery, after going under a manual manipulation on (b)(6) 2022 by my current orthopedic doctor, who informed me that the procedure did not work.I will have to have a revision surgery with the left knee with a new knee implant, but it will not be depuy system.My primary doctor says that this is not acceptable, and i agree.I am 59 years old, but walking like an 80-year-old.This surgery is no walk in the park, and i would like to know what legal action i can take against the manufacturer of this implant.I have an implant that is not doing what it is designed to do.I feel that our doctors that we trust to care for us, should have informed their patients about any knee implant recalls.I have all of my discharge papers and reports from my old doctor's office.I have reached out to some attorney's offices, but i was told they could not represent me until after i have revision surgery.The patient is important.All doctors should listen to their patient.I cannot even flex the left leg.I am at about 65% range of motion, and it should be 90 or better.The patient is right.I know my body, and i know when something is not right.Nobody listened to me.In 2020 of june, i went to another ortho doctor, and he did not understand why i still dealing with limping, and severe stiffness.He put me through two painful tests to see if there was any fluid in the knees, and it was not.Waste of time and money, and was paid by my insurance company.No answers, my obgyn doctor recommended my old ortho doctor, who treated me for a meniscus tear many years ago.I am under his care, and i have an appt at the end of october of this year to discuss revision of the left knee with a new knee implant product.He does not use depuy.Thank goodness.Fda safety report id# (b)(4).

• Brand Name: DEPUY (ATTUNE KNEE SYSTEM)
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 15462233
• MDR Text Key: 300378327
• Report Number: MW5112172
• 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: 09/17/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALEVE OR ; EZETIMIBE; FLUTICASONE NASAL SPRAY WHEN NEEDED; HYDROCHLOROTHIAZIDE ; IRON; LISINOPRIL ; LORATADINE; MOTRIN-ARTHRITIS WHEN NEEDED.; OZEMBIC; SYNTHROID; TYLENOL OR ; VITAMIN C; VITAMIN D-3; WOMEN'S MULTIPLE
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American