MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: reverse glenosphere baseplate 3201504.Humeral stem or stemless 3000113.Reverse humeral liner 3203803.Reverse humeral tray 3201000.
Event or Problem Description
It was reported via clinical study, that approximately 18 months postop the initial implant, this 73 yo male patient was experiencing severe pain for 2 months.X-ray result shows an aseptic glenoid loosening.Patient was prescribed soft rehabilitation involving shoulder and spine as he suffers from cervical spine pathology which could explain the pain.The patient¿s outcome was last known as continuing.The case report form indicates this event is unlikely related to device and definitely not related to procedure.Devices will not be returned.
Additional Manufacturer Narrative
Section h10: (h3) the pain reported may be due to a combination of aseptic (non-infected) glenoid loosening and the patient¿s cervical spine pathology.However, this cannot be confirmed because no radiographs were provided, and the patient has not been revised.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the right side.Subsequently, the patient experienced aseptic glenoid loosening with severe pain "evolving since 2 months post-operative".X-ray shows an aseptic glenoid loosening.As a result, the patient was prescribed soft rehabilitation involving shoulder and spine as he suffers from cervical spine pathology which could explain the pain; however, approximately 1.5 years after initial replacement, the patient underwent a right shoulder revision.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
D10: 300-01-13 - eq humeral stem primary, press fit 13mm: (b)(6).320-38-03 - equinoxe rev 38mm humeral liner +2.5: (b)(6).320-10-00 - equinoxe reverse adapter plate tray +0: (b)(6).320-01-38 - equinoxe reverse 38mm glenosphere: (b)(6).320-15-05 - eq rev locking screw: (b)(6).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d7a, d10, g3, and h11.The following sections were corrected: a2, b1, b5, d1, d4 - catalog, exp.Date, udi#, h4, h6 - clinical and impact codes, type of investigation, findings and conclusions.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A review of complaint history was unable to be performed as the relevant device and event information was unknown.A definitive root cause was unable to be determined; however, may be due to a combination of aseptic (non-infected) glenoid loosening and the patient¿s cervical spine pathology.However, the loosening cannot be confirmed and any potential contributions from user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was 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 RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17475891
• Report Number: 1038671-2023-01886
• Device Sequence Number: 12608339
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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: 320-15-04
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 06/04/2025
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/21/2023; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 204 LB