MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER COMPONENTS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	36MM HUMERAL LINER +0 UNCONSTRAINED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: serial number item number and full description (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6) 320-35-01 - small glenoid plate.(b)(6) 320-31-36 - glenosphere, 36mm.
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2020.The patient presented had deep infection.The case report form indicates that this event is definitely not related to device, possibly related to procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d10, e1, h6, h11.The following sections were corrected: d1, d2a, d2b, d4, h4, h6.D10: 320-36-00 - 36mm humeral liner +0 unconstrained: (b)(6); 320-10-00 - eq rev tray adapter plate tray +0: (b)(6); 300-01-09 - eq humeral stem primary, press fit 9mm: (b)(6); 320-35-01 - eq small glenoid plate: (b)(6); 320-31-36 - equinoxe glenosphere, 36mm: (b)(6).H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, it may be related to an underlying patient condition and/or the surgical procedure.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17850963
• Report Number: 1038671-2023-02416
• Device Sequence Number: 6830834
• Product Code: PHX
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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
• Device Expiration Date: 05/31/2025
• Device Model Number: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Device Catalogue Number: 320-36-00
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White