MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6), 300-20-02 - equinox square torque define screw drive kit.(b)(6), 310-01-44 - equinoxe, humeral head short, 44mm (alpha).(b)(6), 314-13-02 - equinoxe cage glenoid small, alpha.
Event or Problem Description
It was reported that approximately 87 months after a right total shoulder replacement procedure, the patient underwent a revision procedure to address humeral stem loosening.Patient revised to exactech devices.Reported event is not related to the breakage of a device, there was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Manufacturing-related consideration: no manufacturing process-related non-conformances, deviations, or exceptions are associated with this manufacturing lot of humeral stems.Therefore, this does not appear to be manufacturing-related.User-related considerations: there were no user-related issues reported that appear to have contributed to the reported event.Patient-related considerations: there were no patient-related issues reported that appear to have contributed to the reported event.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.This follow-up report is being submitted to relay corrected information.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19623790
• Report Number: 1038671-2024-02168
• Device Sequence Number: 12332801
• Product Code: HSD
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• 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: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 300-01-10
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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 Age: 80 YR
• Patient Sex: Female