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

Model Number	36MM HUMERAL LINER +0 UNCONSTRAINED
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	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 77 yo female patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 2 months post the initial procedure.The patient was revised due to a dislocation from their previous surgery.The patient¿s glenosphere and liner were exchanged to a constained liner to provide better stability.There were no device breakages or surgical delay during the procedure.The patient was last known to be in stable condition following the event.No explanted devices are available for return as the hospital disposed of the devices.No photos of the devices or x-rays were able to be provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (b)(6) - 315-35-00 - glnd kwire (b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) - 320-15-05 - eq rev locking screw (b)(6) - 320-20-00 - eq reverse torque defining screw kit (b)(6) - 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) - 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) - 320-31-36 - glenosphere, 36mm (b)(6) - 320-35-01 - small glenoid plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the geosphere, liner and adapter tray were appropriately released for distribution.The reason for the patient's infection and subsequent revision procedure as related to the devices cannot be conclusively determined.There was no medical or clinical information provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H6: corrected medical device problem code, component code, type of investigation, and investigation conclusions.Manufacturer narrative updated: based on review of all available information, there is no evidence to suggest that the reported event is related to any product problems or use issues.The cause of the dislocation cannot be conclusively determined; however, the reported dislocation may have been related to several potential factors including but not limited to the implant selection, the surgical procedure itself, patient anatomical issues, patient activity after surgery and/or underlying patient medical conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4(remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h4 (remove erroneous date from initial report), h6: clinical code, medical device problem code, component code, types of investigation.Based on review of all available information, there is no evidence to suggest that the reported event is related to any product problems or use issues.The cause of the dislocation cannot be conclusively determined; however, the reported dislocation may have been related to several potential factors including but not limited to the implant selection, the surgical procedure itself, patient anatomical issues, patient activity after surgery and/or underlying patient medical conditions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE SHOULDER COMPONENT
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18882777
• Report Number: 1038671-2024-00468
• Device Sequence Number: 7550805
• Product Code: KWS
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 12/01/2025

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: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Device Catalogue Number: 320-36-00
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 10/09/2024; 11/24/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/30/2024; 10/10/2024; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female