MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 38MM HUMERAL CONST LINER +2.5

Model Number	320-38-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical device(s): 320-10-00, 53479003, equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
Approximately 6.5 yrs postop the initial implant, the (b)(6) male patient dislocated the right reverse shoulder which led to the revision surgery.The surgeon stated the humeral liner became disassociated from the humeral tray which caused the dislocation of the reverse shoulder and the revision surgery to reduce the reverse shoulder.Patient was stable when leaving the operating room.Devices to be returned.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 11-jun-2018.(h3) the revision reported in (b)(4) 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.(h4) device manufacture date: 13-jun-2013.*no information provided in the following section(s): a4, a5, b6, b7, g8, h7, h9.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 38MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10023928
• Report Number: 1038671-2020-00283
• Device Sequence Number: 3117021
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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: 06/11/2018
• Device Model Number: 320-38-13
• Device Catalogue Number: 320-38-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 05/05/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR