MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM GLENOSPHERE

Catalog Number 320-01-38

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): eq rev locking screw (cat# 320-15-05/ sn# (b)(4)).Equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / 6110862).

Event Description

This male patient¿s right total shoulder arthroplasty was performed on (b)(6) 2019.This patient had dislocated his shoulder and a revision was completed on (b)(6) 2019.The surgeon removed the humeral liner, glenosphere and locking screw.After trialing components a new expanded glenosphere to lateralize the center of rotation was chosen.The shoulder was then trialed with a +0 constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, and the shoulder was reduced and closed.The patient was last known to be in stable condition following the event.Implants not returned due to hospital policy.All available information received at this time.

Manufacturer Narrative

Section h10: (h3) approximately 2 months.Postop the initial procedure, this male patient¿s right total shoulder dislocated his shoulder and a revision was completed.The surgeon removed the humeral liner, glenosphere and locking screw.After trialing components, a new expanded glenosphere to lateralize the center of rotation was chosen.The shoulder was then trialed with a +0 constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, and the shoulder was reduced and closed.The patient was last known to be in stable condition following the event.Implants not returned due to hospital policy.All available information received at this time.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 cause of the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient conditions.Section h11: the following sections have corrected information: (b5) describe event or problem: approximately 2 months.Postop the initial procedure, this male patient¿s right total shoulder dislocated his shoulder and a revision was completed.The surgeon removed the humeral liner, glenosphere and locking screw.After trialing components, a new expanded glenosphere to lateralize the center of rotation was chosen.The shoulder was then trialed with a +0 constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, and the shoulder was reduced and closed.The patient was last known to be in stable condition following the event.Implants not returned due to hospital policy.All available information received at this time.

Event Description

Approximately 2 months.Postop the initial procedure, this male patient¿s right total shoulder dislocated his shoulder and a revision was completed.The surgeon removed the humeral liner, glenosphere and locking screw.After trialing components, a new expanded glenosphere to lateralize the center of rotation was chosen.The shoulder was then trialed with a +0 constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, and the shoulder was reduced and closed.The patient was last known to be in stable condition following the event.Implants not returned due to hospital policy.All available information received at this time.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 38MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9519280
• MDR Text Key: 176435164
• Report Number: 1038671-2019-00620
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention