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

Catalog Number	320-01-42
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	01/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient's left shoulder was revised due to infection.No breakage of device or surgical delay/prolongation.Patient required prolonged hospitalization as a direct result of this issue.No other patient information/medical history reported.Product not returning - disposed by hospital.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): (b)(4), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(4), 320-01-42 - equinoxe reverse 42mm glenosphere.(b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(4), 320-15-03 - rs glenoid plate post aug, 8 deg, left.(b)(4), 320-15-05 - eq rev locking screw.(b)(4), 320-20-00 - eq reverse torque defining screw kit (b)(4), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(4), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(4), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(4), 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(4), 531-78-20 - shouldr 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
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from the initial report-suspect device unknown), g2 (australia), g4 (remove 501k from the initial report-unknown) h6: health effect clinical code, health effect- impact code, type of investigation and investigation findings.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 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: kate jacobson ; 3523771140
• MDR Report Key: 16417330
• Report Number: 1038671-2023-00196
• Device Sequence Number: 3364869
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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 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: 02/02/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 03/03/2026
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/18/2023; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: Male