MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Model Number	320-02-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): eq rev locking screw - 320-15-05, (b)(4).Eq rs 42mm humeral liner +2.5 - 320-42-03, (b)(4).
Event or Problem Description
As reported, approximately 26 months after the initial implant, this (b)(6) y/o male patient presented to surgeon with some shoulder instability in their reverse shoulder after over a year of good function and stability.Surgeon was able to dislocate in office and elected to upside components surgically to achieve stability.Surgeon upsized the 42mm glenosphere to a 46mm.Also removed a 42 x 2.5mm liner and replaced with a 46 x 2.5mm constrained liner.Surgeon expects a great outcome and patient left the operating room in stable condition.Devices will not return due to hospital policy.
Additional Manufacturer Narrative
(h3) upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10199548
• Report Number: 1038671-2020-00322
• Device Sequence Number: 16412497
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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 Model Number: 320-02-42
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR