MAUDE Adverse Event Report: DEPUY ATTUNE

Device Problem Material Integrity Problem (2978)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

I had a total knee replacement (b)(6) 2014 and thought that my issues with pain, swelling, lack of bending would be minimalized.I am very disappointed and recently came back from vacation with my family and tried to ride a roller coaster, but my knee would not bend far enough for me to ride it and was not allowed on it for safety reason.I am not even close to being overweight.I am (b)(6) and used to be active until i can't function without the knee swelling and pain etc.Is there a recall for the attune tkr? what can be done about it?.

• Brand Name: ATTUNE
• Type of Device: ATTUNE
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5935388
• MDR Text Key: 54291825
• Report Number: MW5064591
• 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: 09/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 104