MAUDE Adverse Event Report: DEPUY DEPUY ATTUNE; PROSTHESIS, KNEE

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Failure of Implant (1924); Neuropathy (1983); Weakness (2145); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/13/2015

Event Type  Injury  

Event Description

I had total knee replacement on my left knee on (b)(6) 2015.I had physical therapy for approx 5 months.I still needed further therapy but my coverage went no further.I had weakness and knee buckling which continued.I continued to go to the gym trying to strengthen on my own.I was not pleased with the doctor i went to because unlike all i had read and people who i talked to who had the surgery my outcome was different.When i came out of surgery, my knee was four times larger than originally and i could not move it.I was in a rehab facility for 18 days.However, later in 2015, i researched and found a very good doctor and talked to him about my right knee but mention to him that my left knee needed to be stronger.I had surgery on my right knee on (b)(6) 2016 which was totally different from my first surgery.My knee was slightly swollen and i could move it freely.I fact i was putting most of the weight on the new knee because of my left being weak.When i start physical therapy the prescription was for both knees and this time my physical therapy was done with (b)(6) the institute my doctor was affiliated with.Most of the work was on the older knee which i could not straighten it had a terrible lag.After 3 months, my doctor took a further look at my left leg and sent me to have an emg.He drew fluid from the leg.I was sent to a neurologist because the test revealed a slight neuropathy.The neurologist order blood work and it was determined that it was not the problem for the weakness.My surgeon said we would wait a couple more months for my right leg to be healed and we would do an mri.In (b)(6) i had a fall because the left completely collapsed.I had the mri and more blood work done and it was determined that my problem was mechanical.I was rescheduled for surgery on (b)(6) 2016 where i had a total knee replacement revision.The product was in my leg and removed during that procedure was a depuy attune.I was told that every screw was loosened.The implant was not, screws had come loose.I want to make this known so this hopefully will not happen to anyone else.

• Brand Name: DEPUY ATTUNE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): DEPUY
• MDR Report Key: 6267405
• MDR Text Key: 65502131
• Report Number: MW5067363
• Device Sequence Number: 1
• Product Code: MBH
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID ; ASPIRIN; B12; DEZOLOMITA; ENALAPRIL; LASIX; MAGNESIUM; MULTIVITAMIN ; PANTAPRAZOL; TIMINOL; VITAMIN D
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 74 YR
• Patient Weight: 115