MAUDE Adverse Event Report: DEPUY SYNTHES, INC. DEPUY ATTUNE, MOBILE BEARING - TOTAL KNEE REPLACEMENT; PROSTHESIS, KNEE,PATELLO FEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, METAL BE

Lot Number 8173831;8245920;8039458;805907

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Sepsis (2067)

Event Date 04/06/2016

Event Type  Injury  

Event Description

Sepsis 5 weeks after tka; loosening- tibia and patella, revision needed.

• Brand Name: DEPUY ATTUNE, MOBILE BEARING - TOTAL KNEE REPLACEMENT
• Type of Device: PROSTHESIS, KNEE,PATELLO FEMOROTIBIAL, SEMI-CONSTRAINED, METAL/POLYMER, METAL BE
• Manufacturer (Section D): DEPUY SYNTHES, INC.
• MDR Report Key: 8286350
• MDR Text Key: 134694222
• Report Number: MW5083439
• 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: Patient
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 8173831;8245920;8039458;805907
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 100