MAUDE Adverse Event Report: DEPUY ATTUNE KNEE REPLACEMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/22/2016

Event Type  Injury  

Event Description

I had an attune depuy knee replacement put into my left knee and i have had pain and stiffness ever since (b)(6) 2016.I've had at least 35 physical therapies and one mua but i get nowhere.This has ruined my life as i have had to miss important engagements and my work, plus i just feel crappy all the time in pain and not well-being.Doctor took fluid but it showed no infection.Second opinion said that i need to have it done over with a new tkr.

• Brand Name: ATTUNE KNEE REPLACEMENT
• Type of Device: ATTUNE KNEE REPLACEMENT
• Manufacturer (Section D): DEPUY
• MDR Report Key: 6553944
• MDR Text Key: 74826930
• Report Number: MW5069646
• Device Sequence Number: 1
• Product Code: JWH
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ABLE TO SLEEP SINCE OPERATION. ; OTC MEDS: MULTIPLE VITAMINS. ; RX MEDS: TEMAZEPAM BECAUSE I HAVE NOT BEEN,
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 70 YR
• Patient Weight: 60