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

Catalog Number	320-02-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9512872
• Report Number: 1038671-2019-00619
• Device Sequence Number: 14007540
• Product Code: KWT
• UDI-Device Identifier: 10885862186751
• UDI-Public: 10885862186751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-02-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention