MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE REVISION TIBIAL BASE FIXED BEARING; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 1506-40-005

Device Problems Break (1069); Defective Component (2292); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Knee total arthroplasty.Tibial component was grossly loose.Appeared defective.Pin sheared with no threads and stem broken off.Implanted (b)(6) 2020, removed and replaced (b)(6) 2022.Fda safety report id (b)(4).

• Brand Name: ATTUNE REVISION TIBIAL BASE FIXED BEARING
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 15864995
• MDR Text Key: 304423697
• Report Number: MW5113486
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1506-40-005
• Device Lot Number: 8503426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 110 KG