MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
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	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)) eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately three months post initial right tsa, the 58 y/o male patient presented with recurring dislocation due to undersized/loose stem.Patient had a replacement of stem, liner, glenosphere, torque screw, and locking screw.There was no reported breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images or x-rays.The devices are not available for evaluation due to they were disposed by hospital.No further information provided.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of humeral stem loosening and subsequent dislocation.The loosening may have been due to undersizing the stem, as stated in the experience report.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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: miguel soza
• MDR Report Key: 18763871
• Report Number: 1038671-2024-00312
• Device Sequence Number: 7795552
• Product Code: KWT
• 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,Followup
• Report Date (Section B): 07/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 06/04/2026; 07/28/2026
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/25/2026; 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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: EQ REV COMPRESS SCREW LCK CAP KIT; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW; EQUINOXE REVERSE 42MM GLENOSPHERE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male