MAUDE Adverse Event Report: DEPUY/ J AND J DEPUY ATTUNE

Model Number SIZE 6

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/24/2017

Event Type  Injury  

Event Description

Bone cement doesn't adhere to the tibial component.Implant loosens - severe pain.

• Brand Name: DEPUY ATTUNE
• Type of Device: DEPUY ATTUNE
• Manufacturer (Section D): DEPUY/ J AND J; warsaw IN
• MDR Report Key: 6713886
• MDR Text Key: 80155968
• Report Number: MW5070986
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SIZE 6
• Device Catalogue Number: 8202196
• Device Lot Number: D150600006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR