MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-42
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left shoulder was revised approximately 5 years post initial operation.This was a revision of humeral components.Surgeon believes poly dissociated, patient unsure how incident occurred.When devices were received, there was a visibly damaged glenosphere.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Concomitants: (b)(6) - 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6) - 320-01-42 - equinoxe reverse 42mm glenosphere.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-15-01 - eq rev glenoid plate.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 20-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.V - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) - 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6) - 321-20-00 - equinoxe reverse shoulder drill kit.Product has been received by exactech and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent metal-on-metal articulation between unintended components.This disassembly likely also led to backside wear of the humeral liner.Potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner cannot be confirmed from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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; 2320 nw 66 ct; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22904912
• Report Number: 1038671-2025-02850
• Device Sequence Number: 18414380
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Male