MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products 36mm humeral liner +0 unconstrained (cat# 320-36-00 / serial# (b)(6)) equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine months post initial left tsa, the 78 y/o female had a revision surgery due to heterotopic ossification.Patient had cleared out bone and re-implanted humeral components.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was was unable to obtain photos/x-rays.The devices are not available for evaluation due to the devices were disposed of by hospital.
Additional Manufacturer Narrative
(h3) heterotopic ossification occurs when bone tissue develops in the soft tissue.This can occur near a joint following major surgery and can restrict range of motion.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 heterotopic ossification and subsequent revision is likely due to patient conditions.The following section have corrected information: h6: type of investigation, investigation findings, investigation conclusion.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: matt collins
• MDR Report Key: 19035836
• Report Number: 1038671-2024-00728
• Device Sequence Number: 18189531
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 08/19/2024; 09/29/2026
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: 78 YR
• Patient Sex: Female