MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-13
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.315-35-00 - glnd kwire.320-01-46 - equinoxe reverse 46mm glenosphere.320-10-15 - eq rev locking screw.320-15-07 - sup/post aug plate, l rs glenoid baseplate.320-20-00 - eq reerse torque defining screw kit.320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.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.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.320-46-13 - equinoxe reverse 46mm humeral const liner +2.5.321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
As reported, the patient underwent a revision of a left reverse total shoulder arthroplasty to a competitors reverse shoulder.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear of the humeral liner secondary to malpositioned glenoid components.It remains unclear whether the glenoid components were initially implanted in this position and/or migrated over time.Contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and initial post-operative radiographs were not provided.D1: corrected.D4: corrected.G4: corrected.H6: corrected medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5
• 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
• MDR Report Key: 21006975
• Report Number: 1038671-2024-04997
• Device Sequence Number: 9858297
• Product Code: KWT
• UDI-Device Identifier: 10885862086761
• UDI-Public: 10885862086761
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 08/08/2025

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 Expiration Date: 07/07/2022
• Device Catalogue Number: 320-46-13
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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