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

Catalog Number	314-13-02
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 70 yo female patient, who had a primary rtsa implanted, underwent a revision procedure.The patient noticed issues with motion.Xrays were taken and showed superior shift and the stem in valgus causing some medial resorption on humerus.The surgeon revised the cage glenoid to a tornier baseplate and 36 glenosphere.The stem was well fixed, so he left it in.The surgeon revised the humeral components to our humeral tray and liner (+0mm humeral adapter tray, +2.5mm 36mm humeral liner, reverse torque defining screw kit).There was a 45 minute surgical delay reported with no adverse event to the patient.The report indicated the glenoid cage and pegs were seemingly not in place on the x-rays taken and the delay was due to the revision surgery needed.There were no device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for return as the hospital keeps them.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
D10: concomitants: 6709846300-10-15 - equinoxe replicator plate 1.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 300-30-10 - equinoxe preserve stem 10mm, (b)(6), 310-01-44 - equinoxe, humeral head short, 44mm (alpha), (b)(6), 315-35-00 - glnd kwire.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 information.The following sections were updated: h3, h6, h11.The reported event was unable to be conclusively determined due to limited information received from the customer.No device was returned for evaluation.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be conclusively determined but may be the result of the glenoid fracture, osteolysis, positioning of the humeral head, and/or superiorly shifted humeral components as reported.The glenoid fracture of the center cage and the observed wear of the glenoid¿s articular surface may have been due to uneven loading of the humeral head on the glenoid leading to eccentric loading about the center peg.Additionally, the shifted humeral components may be due to a rotator cuff deficiency, however it is unclear if the humerus migrated because it was not clearly reported, and the rotator cuff failure was not reported and cannot be confirmed.However, this underlying cause and potential contributions of patient or user-related issues to the event cannot be determined from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• 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: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 22311884
• Report Number: 1038671-2025-02349
• Device Sequence Number: 8948358
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Expiration Date: 08/04/2024
• Device Catalogue Number: 314-13-02
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female