MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo male patient, initial right shoulder implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2023, approximately 5 years 8 months post the initial procedure.The surgeon revised the patient due to a loose stem.All components in the humerus were explanted and the glenoid side was left alone.They were revised to a competitor¿s devices.X-rays were provided.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No device returns are anticipated as the hospital does not release them.A device image was provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 5215003, 300-10-45 - equinoxe replicator plate 4.5mm o/s; 5205280, 300-20-02 - equinox square torque define screw drive kit; 5142925, 310-02-50 - equinoxe, humeral head tall, 50mm (beta); 5321737, 314-13-13 - equinoxe cage glenoid medium, beta.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision may have been due to humeral loosening.However, this can not be confirmed from the information provided.Potential contributions of user and patient-related issues could not be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18468853
• Report Number: 1038671-2024-00040
• Device Sequence Number: 15240143
• Product Code: HSD
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 03/03/2025

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 Model Number: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• Device Catalogue Number: 300-01-12
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/03/2025
• Date Device Manufactured: 02/15/2018
• 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: 67 YR
• Patient Sex: Male