MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER

Catalog Number 320-38-00

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

Resubmission of initial report.The orginial submission was erroneously marked as a follow up 1 it should have been marked as an initial.

Event Description

Index surgery: (b)(6) 2016.Non-revision of right shoulder components due to an acromial stress fracture.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: HUMERAL LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 7450252
• MDR Text Key: 234760537
• Report Number: 1038671-2017-00581
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-00
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Race: White