MAUDE Adverse Event Report: DEPUY DEPUY ATTUNE

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)

Event Date 01/15/2016

Event Type  Injury  

Event Description

Depuy attune knee implant is failing.Instability in my knee.Constant severe pain.Loss of mobility and strength.Knee gives out (even with a brace).Popping, clicking and clunking sounds.Knee is constantly warm to the touch.

• Brand Name: DEPUY ATTUNE
• Type of Device: DEPUY ATTUNE
• Manufacturer (Section D): DEPUY
• MDR Report Key: 5910110
• MDR Text Key: 53466827
• Report Number: MW5064379
• 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: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Weight: 91