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

Catalog Number	304-22-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Dislocation (2374); Aseptic loosening (4883)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 52 yo male patient, initial right shoulder implanted in (b)(6) 2024, underwent a revision procedure in (b)(6) 2025.The patient had been dislocating and had limited range of motion due to non-compliance of exercise.During the procedure the stem was found to be loose.Cement was on the implant only and not on the bony interface.The surgeon used the same size stem as previously inserted.The glenoid was changed as the surgeon wanted a larger surface area to prevent dislocation.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.They were disposed of by the hospital.No images were available.No further information.This is 1 of 2 reports.See mdr# 1038671-2025-01866.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 315-35-00 - glnd kwire.(b)(6) 321-52-07 - 3.2mm drill bit sterile.(b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of dislocation and/or limited range of motion as reported.Additionally, the humeral loosening reported to be found during the revision procedure was likely the result of an insufficient bond between the cement and surrounding bone interface.The dislocation and limited range of motion could be due to the patient's non-compliance of post-surgery exercises; however, it is unclear whether the humeral loosening contributed to the reported event.The dislocation, loosening, and limited range of motion cannot be confirmed and contributions from user-related considerations could not be assessed as the devices were not returned for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21877647
• Report Number: 1038671-2025-01867
• Device Sequence Number: 8769123
• Product Code: KWT
• UDI-Device Identifier: 10885862083401
• UDI-Public: 10885862083401
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 04/24/2025

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 Catalogue Number: 304-22-11
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male