MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM GLENOSPHERE

Model Number	320-01-46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-10-15, humeral tray +15mm; 320-46-13, equinoxe reverse 46mm humeral const liner +2.5; 320-20-00, eq reverse torque defining screw kit; 320-15-05, eq rev locking screw.
Event or Problem Description
As reported, approximately 5 years postop, this (b)(6) y/o male¿s shoulder was dislocated.After opening the shoulder, it was identified that the poly liner was disassociated from the humeral tray.After trialing, the surgeon chose to re-implant the same sized components that were removed.Patient was last known to be in stable condition following the event.Patient asked for devices, devices will not be returned to the manufacturer.
Additional Manufacturer Narrative
Serial number: (b)(6), expiration date: 27-apr-2024.The revision reported was likely the result of a combination of the dislocation and the humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation led to the dislocation, which may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient conditions, or a combination of the three.Device manufacture date: 30-apr-2014.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9956679
• Report Number: 1038671-2020-00273
• Device Sequence Number: 11465143
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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 Expiration Date: 04/27/2024
• Device Model Number: 320-01-46
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 08/21/2020
• 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
• Patient Age: 67 YR