MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL LINER

Catalog Number 9999

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: 2012.Revision due to peri-prosthetic fracture when patient fell.It was performing and functioning normally with no issues but the patient then fell and fractured their humerus, causing a peri-prosthetic fracture just below the humeral stem.The stem, humeral tray, torque defining screw and humeral liner were removed and replaced with a long humeral stem and the relevant other components.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of the patient's fall, which caused a fracture of the humerus just below the humeral stem.

• Brand Name: HUMERAL LINER
• Type of Device: LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville
• MDR Report Key: 8085145
• MDR Text Key: 127591129
• Report Number: 1038671-2018-00881
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention