MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL HEAD

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Patient fell.Revised due to failed glenoid.

Event Description

It was reported that the patient fell and most likely caused the anatomic glenoid cage to break in several pieces and the poly to come loose.The patient was converted to a reverse shoulder and everything was reported to look good.There is no indication that the devices malfunctioned.No additional information is provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00797, 1038671-2017-00801, 1038671-2017-00802.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level and/or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the revision for the shoulder joint device is related to trauma from the patient fall.This device is used for treatment, not diagnosis.

• Brand Name: HUMERAL HEAD
• Type of Device: HEAD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7000298
• MDR Text Key: 90996668
• Report Number: 1038671-2017-00803
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR