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	06/19/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(device evaluated by mfr): pending evaluation.Concomitant medical products: 320-46-00 ,2545420 - equinoxe reverse 46mm humeral liner +0, 320-20-00, 2837137 - eq reverse torque defining screw kit, 320-10-00, 2851073 - equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, approximately 5 mos.Postop the initial implant, a (b)(6) y/o male with a ¿larger frame¿ came to the or with his right shoulder dislocated.After opening the shoulder, it was identified that the poly liner was disassociated from the humeral tray.After trailing, the surgeon chose to implant the same sized components that were removed.Devices will not be returned.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) 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 patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 46MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10162479
• Report Number: 1038671-2020-00308
• Device Sequence Number: 14400886
• 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: 2014
• 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: 320-01-46
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 06/17/2020
• 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