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

Catalog Number	320-15-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left shoulder was revised approximately 4 years post initial operation.The patient had an infection.The surgeon revised all components except the stem.Patient was last known to be in stable condition following the event.There was no breakage of the device.The devices were not available for evaluation due to the devices being disposed.No images or radiographs were provided.
Additional Manufacturer Narrative
D10: 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; 320-01-42 - equinoxe reverse 42mm glenosphere; 320-15-05 - eq rev locking screw; 320-20-00 - eq reverse torque defining screw kit; 320-42-03 - equinoxe reverse 42mm humeral liner +2.5.300-01-13 - equinoxe, humeral stem primary, press fit 13mm.The reason for the reported revision due to suspected infection cannot be conclusively determined; however, it may be related to an underlying patient condition.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d3, d4, g4, h4 - please disregard all device information.D10 concomitants: 300-01-13 - equinoxe, hum stem primary, press fit 13mm: (b)(6).320-10-00 - equinoxe rev tray adapter plate tray +0: (b)(6).320-15-01 - eq rev glenoid plate: (b)(6).320-20-22 - eq rev comp screw lck cap kit, 4.5 x 22mm: (b)(6).320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm; (b)(6).320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev comp screw lck cap kit, 4.5 x 30mm: (b)(6).320-01-42 - equinoxe reverse 42mm glenosphere: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-42-03 - equinoxe reverse 42mm humeral liner +2.5: (b)(6).H6: component code.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21857973
• Report Number: 1038671-2025-01845
• Device Sequence Number: 11933319
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 320-15-01
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male