MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE, 36MM

Model Number	320-31-36
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 months postop the primary l tsa, this (b)(6) female presented with a sudden onset of pain without an inciting event.Clinical scapular spine fracture was not visualized on x-ray.The patient has a pre-op history of avascular necrosis of humeral head.The reported action taken was to wear a sling and relative rest.Outcome reported as resolved on (b)(6) 2021.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.Devices will not return due to study policy.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-30-06 - equinoxe preserve stem 6mm; 320-36-00 - 36mm humeral liner +0 unconstrained; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-35-01 - small glenoid plate.
Additional Manufacturer Narrative
(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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Common Device Name: GLENOSPHERE, 36MM
• 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: 13052856
• Report Number: 1038671-2021-00716
• Device Sequence Number: 11750102
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 320-31-36
• Device Catalogue Number: 320-31-36
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White