MAUDE Adverse Event Report: JOHNSON & JOHNSON / DEPUY SYNTHES DEPUY ATTUNE

Device Problems Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Experiencing increasing and persistent pain and discomfort one year after full knee replacement surgery.My orthopedist who performed knee replacement "suspects" the problem is due to the depuy attune device coming loose.He has ceased using this device due to similar complaints from others.He stated that revision surgery may be required in the future.

• Brand Name: DEPUY ATTUNE
• Type of Device: DEPUY ATTUNE
• Manufacturer (Section D): JOHNSON & JOHNSON / DEPUY SYNTHES
• MDR Report Key: 7880668
• MDR Text Key: 120573349
• Report Number: MW5079832
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 80 YR
• Patient Weight: 82