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

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	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately (b)(6) months post op initial right tsa.This 73 y/o male patient was revised, due to infection.Liner, tray, glenopshere were removed and replaced.Patient was last known to be in stable condition following the event.Product not returning.Hospital did not return.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere; (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm; (b)(6), 315-35-00 - glnd kwire; (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere; (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-04 - rs glenoid plate post aug, 8 deg, right; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-18 - eq rev compress screw lock cap kit, 4.5 x 18mm; (b)(6), 320-20-18 - eq rev compress screw lock cap kit, 4.5 x 18mm; (b)(6), 320-20-22 - eq rev compress screw lock cap kit, 4.5 x 22mm; (b)(6), 531-78-20 - shoulder gps hex pins kit; (b)(4), a10012 - gps implant kit v2.
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 infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been 16-dec-2023.(g6) type of report - 30-day should have been checked along with follow-up.
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 subsequent revision 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: d1, d4(remove expiration date), g1, g4, h1, h4 (remove manufactured date), h6: clinical code, investigation findings and investigation conclusions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 11 months post op initial right tsa, this male patient was revised due to infection.Liner, tray, glenopshere were removed and replaced.Patient was last known to be in stable condition following the event.Product not returning - hospital did not return.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17549219
• Report Number: 1038671-2023-01949
• Device Sequence Number: 12476219
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 02/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2025
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 01/12/2024; 02/07/2026
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/12/2024; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male