MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 46X21MM GLENOSPHERE HIGH MOMENT ARM

Model Number	320-02-46
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-30-06.Equinoxe preserve stem 6mm.320-46-03, equinoxe reverse 46mm humeral liner +2.5.320-10-05, equinoxe reverse tray adapter plate tray +5.320-15-01, eq rev glenoid plate.
Event or Problem Description
As reported, approximately 7 months postop the initial implant, this female patient¿s left shoulder was revised due to severe glenoid wear and separation from the cage with increased pain.Shoulder was implanted with a hemi.The patient was last known to be in stable condition following the event.The device is not returning due to study protocol.The outcome was reported as resolved.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 30-jun-2030.(h3) the disassembly reported may have been the result of not properly seating the locking screw which allowed for the screw to back out over time and led to subsequent disassembly of the glenosphere.The reported polyethylene wear may have been the result of articulating against other metal components, such as the glenosphere locking screw and/or glenoid baseplate, after the glenosphere disassociation occurred.However, this cannot be confirmed as the devices were not returned for evaluation and x-ray images were not provided.(h4) device manufacture date: 30-jun-2020.Section h11: the following sections have corrected information: concomitant devices: 320-46-03, 6561038 - equinoxe reverse 46mm humeral liner +2.5.320-15-05, 6651730 - eq rev locking screw.

• Brand Name: EQUINOXE
• Common Device Name: 46X21MM GLENOSPHERE HIGH MOMENT ARM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12712353
• Report Number: 1038671-2021-00557
• Device Sequence Number: 19972907
• Product Code: KWT
• UDI-Device Identifier: 10885862286871
• UDI-Public: 10885862286871
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 320-02-46
• Device Catalogue Number: 320-02-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown