MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.(b)(6), 320-06-38 - glenosphere 38mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 320-15-03 - rs glenoid plate l post aug, 8 deg, left.(b)(6), 20-15-05 - eq rev locking screw.(b)(6), 320-20-00 - eq reverse torque defining screw kit.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 321-52-07 - 3.2mm drill bit sterile.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, initial left shoulder implanted in october 2023, underwent a revision procedure on (b)(6) 2025, approximately 1 year 6 months post the initial procedure.The patient was revised due to pain.A new 38 +2.5 poly was inserted with no issues.X-rays were provided.The explanted device is not available for return.No device images were provided.No further information.
Additional Manufacturer Narrative
The reason for the pain reported cannot be conclusively determined but may be related to an underlying patient condition, infection, component loosening, component sizing, positioning, or impingement issues, or a combination of the above.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22004150
• Report Number: 1038671-2025-02035
• Device Sequence Number: 15237698
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 08/13/2025

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: 320-38-00
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: Required Intervention
• Patient Sex: Unknown