MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER

Model Number	EQUINOXE REVERSE 42MM GLENOSPHERE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(4) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(4) 315-35-00 - glnd kwire.(b)(4) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4) 320-15-01 - eq rev glenoid plate.(b)(4) 320-15-05 - eq rev locking screw.(b)(4) 320-20-00 - eq reverse torque defining screw kit.(b)(4) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(4) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(4) 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(4) 531-78-20 - shouldr gps hex pins kit.
Event or Problem Description
It was reported that a 67 yo male patient, had an initial left shoulder implanted on (b)(6) 2022, then underwent a 2-stage revision, approximately 5 months post the initial procedure.The reverse total shoulder was removed for infection as a part of a 2-stage revision.The patient was not revised to exactech devices.There were no reported issues during the surgical revision procedure.The patient was last known to be in stable condition following the event.The products are not returning; implants required for collection of infected materials ¿ sent to hospital pathology.No additional information.
Additional Manufacturer Narrative
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 infection and revision surgery cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4(remove all from the initial report-suspect device unknown) g4 (remove 501k from the initial report-unknown) h1, h6: type of investigation, investigation findings and investigation conclusion and h11 should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15674606
• Report Number: 1038671-2022-01351
• Device Sequence Number: 12363933
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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
• Patient Sex: Male