MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 38MM HUMERAL LINER +2.5

Catalog Number 320-38-03

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to the patient felling directly on to his shoulder and the poly becoming detached from the adapter tray.

Manufacturer Narrative

The revision reported was likely the result of a post traumatic event.¿fracture of the prosthesis or any of its components may require a surgical intervention or revision¿ is listed in the device specific risks section of the equinoxe shoulder system ifu 700-096-060.

Manufacturer Narrative

The following sections have additional info: (g4) date received by manufacturer: 22-feb-2019.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8449287
• MDR Text Key: 139746900
• Report Number: 1038671-2019-00176
• 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,Followup
• Report Date: 08/13/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention