MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET

Catalog Number 320-02-38

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

Patient Problem Joint Dislocation (2374)

Event Date 12/10/2019

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 +2.5 (cat# 320-38-03 /(b)(4)).

Event Description

This male patient¿s original left total shoulder arthroplasty on (b)(6) 2019.The patient was dislocating and was revised on (b)(6) 2019.A second revision was completed on (b)(6) 2019 due to dislocating.The surgeon stated ¿he believes that on the original case, he may not have made it (the shoulder) tight enough.During the revision, the humeral liner was removed along with the glenosphere and locking screw.After trialing components, a new expanded glenosphere to lateralize the center of rotation was implanted.Then trialed with a constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, the shoulder was reduced and closed.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.All available information has been received at this time.

Manufacturer Narrative

Section h10: (h3) approximate 3 mos after the initial implant for this male patient¿s left total shoulder, the patient was dislocating and was revised.Approximately 9 mos postop that revision the patient experienced a second revision due to dislocating.The surgeon stated ¿he believes that on the original case, he may not have made it (the shoulder) tight enough.During the revision, the humeral liner was removed along with the glenosphere and locking screw.After trialing components, a new expanded glenosphere to lateralize the center of rotation was implanted.Then trialed with a constrained liner and decided that this gave the patient a very stable shoulder.All final implants were implanted, the shoulder was reduced and closed.Patient was last known to be in stable condition following the event.Devices were disposed of by the hospital.All available information has been 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 surgeon¿s choice of size of device during implant.

• Brand Name: EQUINOXE
• Type of Device: RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9512872
• MDR Text Key: 176947716
• Report Number: 1038671-2019-00619
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186751
• UDI-Public: 10885862186751
• Combination Product (y/n): N
• PMA/PMN Number: K110708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-02-38
• 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