MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

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 Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4.4 years post initial left tsa, the 77 y/o female patient had all implants explanted due to stem loosening.Patient was revised to competitor's devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays images received.The devices are not available for evaluation due to hospital does not release implants.
Additional Manufacturer Narrative
Section d10: concomitant products - equinoxe replicator plate 4.5mm o/s (cat# 300-10-45 / serial# (b)(4) ) - equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(4) ) - equinoxe, humeral head short, 44mm (alpha) (cat# 310-01-44 / serial# (b)(4) ) - equinoxe cage glenoid small, alpha (cat# 314-13-02 / serial# 5(b)(4) 580387) 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 following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of prothesis wear.Additional reasons for the reported revision may be humeral loosening and the inclusion of the polyethylene in the packaging recall.However, the reported humeral loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17261607
• Report Number: 1038671-2023-01541
• Device Sequence Number: 7966892
• Product Code: KWT
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 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: 06/12/2023
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female