MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: equinoxe shoulder study; subject: ay-150-l.It was reported via clinical study, that approximately 15 months postop the initial implant, this 67 yo male patient¿s shoulder was revised due to disassociation of polyethylene.The polyethylene dissociation occurred when reaching to pet dog and hearing a "pop".The patient¿s outcome was last known as resolved.The case report form indicates this event is definitely related to device and possibly related to procedure.Devices will not be returned.
Additional Manufacturer Narrative
D10.Concomitant: humeral stem or stemless 300-30-07.Reverse glenosphere 320-06-38.Reverse humeral tray 320-10-00.Reverse glenosphere baseplate 320-15-02.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
Reported via legal, several months following initial implantation, the patient began to experience alarming grinding and cracking noises, accompanied by significantly increased pain compared to their condition prior to the surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in may have been due to disassembly of the humeral liner and humeral tray.However, the reported disassembly could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event, 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 reported disassembly of the humeral liner cannot be determined, as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE 38MM 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; 3525541928
• MDR Report Key: 17471306
• Report Number: 1038671-2023-01880
• Device Sequence Number: 2647677
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2025

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: 05/19/2026
• Device Catalogue Number: 320-38-13
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 04/22/2025; 06/04/2025
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 05/06/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White