MAUDE Adverse Event Report: ZIMMER BIOMET ATTUN TKR; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2019

Event Type  malfunction  

Event Description

Patient underwent primary tkr (zimmer biomet) which failed.Patient underwent 1st revision where a zimmer biomet revision knee system was utilised - this failed.The patient underwent revision tkr where and attune revision system was utilised - this has failed.Original implant date unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ATTUN TKR
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17524537
• MDR Text Key: 321246404
• Report Number: MW5131483
• 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: Other
• Type of Report: Initial
• Report Date: 01/31/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1