MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	HUMERAL HEAD SHORT, 50MM (BETA)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Arthropathy (4894)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 300-21-00 - 0mm fixed angled kit 7195549.304-21-13 - 12.5mm platform fx stem left 6715604.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 51 year-old male patient who had an initial left shoulder arthroplasty on (b)(6) 2022, was revised on (b)(6) 2023, approximately 10 months post the initial procedure.The revision procedure was for failed rotator cuff in l) hemi-arthroplasty, performed for proximal humeral fracture in 2022.All components were revised and converted to a reverse total shoulder replacement using equinoxe system.No surgical delays reported.Patient was last known to be in stable condition following the event.No device returns anticipated.The implants were required for collection of infected materials and were sent to hospital pathology.No further information.
Additional Manufacturer Narrative
H6: upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or instability of total joint hardware.The most likely cause of the reported event is the patient¿s activity and the surgeon¿s choice of initial implant.

• Brand Name: EQUINOXE
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16556690
• Report Number: 1038671-2023-00451
• Device Sequence Number: 2970165
• Product Code: HSD
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: HUMERAL HEAD SHORT, 50MM (BETA)
• Device Catalogue Number: 310-01-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/11/2026
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 07/05/2023; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 198 LB