MAUDE Adverse Event Report: DEPUY ATTUNE KNEE SYSTEM

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Type  No Answer Provided  

Event Description

Injured at work and had a depuy attune knee implanted in 2016.It's a year later and my knee feels like the inside is constantly burning, swelling and persistent pain.An x-ray only show the figure of the patella but not underneath and you can't use an mri because of the metal.I need answers, with all complaints about the attune system, "why haven't the fda recalled it.".

• Brand Name: ATTUNE KNEE SYSTEM
• Type of Device: ATTUNE KNEE SYSTEM
• Manufacturer (Section D): DEPUY
• MDR Report Key: 6998888
• MDR Text Key: 91088928
• Report Number: MW5073121
• 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: Other
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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
• Patient Age: 55 YR
• Patient Weight: 79