MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE KNEE REPLACEMENT; PROSTHESIS, KNEE, PATELLA FEMOROTIBIAL, SEMI CONSTRAINED, METAL POLYMER

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

Reporter called from another manufacturer to report major issues with the depuy attune knee replacement.Reporter stated that they have seen approximately 50 revisions of this specific knee, where the baseplate just falls out.Reporter stated that depuy made a running change to address the problem with the attune knee replacement baseplate, but feels that the device should be recalled.Reporter stated that depuy is aware of the issues with the device but continues to hide it from the fda.

• Brand Name: ATTUNE KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE, PATELLA FEMOROTIBIAL, SEMI CONSTRAINED, METAL POLYMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 8185893
• MDR Text Key: 131374384
• Report Number: MW5082340
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• 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