MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRIMARY SHOULDER COMPONENT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 42MM GLENOSPHERE
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately four years post initial right tsa, the 75 y/o male patient had a revision due to dislocation.Patient was revised to an exactech devices.Glenosphere and locking screw were replaced.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photo/x-rays.The devices are not available for evaluation because they were discarded by hospital.No additional information available.
Additional Manufacturer Narrative
Section d10: concomitant product: eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: as reported, approximately four years post initial right tsa, the 75 y/o male patient had a revision due to dislocation.Patient was revised to an exactech devices.Glenosphere and locking screw were replaced.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photo/x-rays.The devices are not available for evaluation because they were discarded by hospital.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, g3 (correction to initial report- 22-apr-2023, h6: medical device problem code, component code, investigation types, findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENT
• 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 jacbson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16898698
• Report Number: 1038671-2023-00953
• Device Sequence Number: 15162767
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2025

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 REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 12/01/2025
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/10/2023; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2019
• 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 GLENOID PLATE.; EQ REVERSE TORQUE DEFINING SCREW KIT.; EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0.; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male