MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE TIBIA PLATE; TEMPLATE

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Depuy attune tibia plate failure.Fda safety report id# (b)(4).

• Brand Name: ATTUNE TIBIA PLATE
• Type of Device: TEMPLATE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 15321029
• MDR Text Key: 298982679
• Report Number: MW5111773
• Device Sequence Number: 1
• Product Code: HWT
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White