MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC ATTUNE LCS; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number ATTUNE

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2020

Event Type  malfunction  

Event Description

Patient in operating room for right total knee arthroplasty.During case in process, i was informed that ps fem trial sz 5l broke in half after doctor hammered trail in place.Both pieces were removed per surgeon.Doctors and rns removed all pieces removed from patient.Depuy rep was present and aware.Depuy rep took picture.

• Brand Name: ATTUNE LCS
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC; 700 orthopaedic dr; warsaw IN 46582
• MDR Report Key: 9877386
• MDR Text Key: 184846527
• Report Number: 9877386
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2020,02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATTUNE
• Device Lot Number: D254500725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2020
• Date Report to Manufacturer: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA