MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD EXPANDED, 47MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	300-10-45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.It is known that patient¿s age, weight, and activity level, would cause the surgeon to expect early failure of the system.Concomitant medical products: 300-20-02 - equinox square torque define screw drive kit 6912735, 310-03-47 - equinoxe, humeral head expanded, 47mm (beta) 4184470.
Event or Problem Description
As reported, approximately 9 months post op the right reverse total shoulder arthroplasty of this 69 y/o male patient was revised.The patient presented with glenoid erosion from a hemi in place and was revised to exactech reverse humeral components and other manufactures glenoid components.There were no reported issues with the revision procedure.The patient was deemed stable after the procedure.The devises will not be returned due to hospital policy.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4, d8, h4, h6: clinical code and investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 9 months post operation the right reverse total shoulder arthroplasty of this male patient was revised.The patient presented with glenoid erosion from a hemi in place and was revised to exactech reverse humeral components and other manufactures glenoid components.There were no reported issues with the revision procedure.The patient was deemed stable after the procedure.The devises will not be returned due to hospital policy.No additional information.

• Brand Name: EQUINOXE, HUMERAL HEAD EXPANDED, 47MM (BETA)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16016670
• Report Number: 1038671-2022-01610
• Device Sequence Number: 12404652
• Product Code: HSD
• UDI-Device Identifier: 10885862083975
• UDI-Public: 10885862083975
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/20/2026

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 Expiration Date: 11/17/2025
• Device Model Number: 300-10-45
• Device Catalogue Number: 310-03-47
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male