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

Model Number	320-31-36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this (b)(6) y/o female patient presented with right shoulder pain.A revision was scheduled.The surgeon removed the humeral tray, liner and glenosphere.He replaced them with a 40+4 glenosphere, neutral liner and a +10 humeral tray.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0 liner.
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 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: 12868089
• Report Number: 1038671-2021-00636
• Device Sequence Number: 19725805
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 06/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 85 KG