MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL LINER, 40MM, +2.5

Model Number	320-40-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This revision was found during the investigation of (b)(4).Reason for the revision is unknown.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 320-32-40, 5993404 - expanded glenosphere, 40mm, for small reverse.320-35-01, 6066265 - small glenoid plate.300-01-15, 6113495 - equinoxe, humeral stem primary, press fit 15mm.320-20-34, 6171767 - eq rev compress screw lck cap kit, 4.5 x 34mm.320-10-00, 6203171 - equinoxe reverse tray adapter plate tray +0.320-15-05, 6217400 - eq rev locking screw.320-20-00, 6224120 - eq reverse torque defining screw kit.320-20-30, 6225658 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Additional Manufacturer Narrative
Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL LINER, 40MM, +2.5
• 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: 13634062
• Report Number: 1038671-2022-00232
• Device Sequence Number: 5039715
• Product Code: KWT
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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 Expiration Date: 01/17/2024
• Device Model Number: 320-40-03
• Device Catalogue Number: 320-40-03
• 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: 05/24/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female