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

Catalog Number	314-13-34
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 70 yo male patient, who had their right shoulder implanted, underwent a revision procedure approximately 6 years 1 month post the initial procedure.The patient was revised due to failure of the anatomic glenoid.The patient had severe lysis as a result of the glenoid polyethene wear.They were converted to a cta head implant as there was not enough bone stock for a reverse glenoid implant.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-ray images were provided.The explanted devices are not available for return as they were disposed of by the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), a10012 - gps implant kit v2, (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta), (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 300-01-15 - equinoxe, humeral stem primary, press fit 15mm, (b)(6), 531-78-20 - shouldr gps hex pins kit.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.According to the information provided the patient was revised due to "failure of the anatomic glenoid".It was also reported that "the patient had severe lysis as a result of the glenoid polyethylene wear.No device was returned for evaluation; photographs of the explanted glenoid were provided; however, the reported event was unable to be confirmed.The review identified that it appeared that the center cage may have worn a hole through the glenoid body.There also appears to be superior articular surface wear." a review of complaint history determined that no further action is required as no trends were identified.The revision reported may be the result of prosthesis wear of the glenoid component and fracture of the central cage.The cause of the fracture may have been due to incomplete seating of the implant, off-axis drilling of the peg holes during implantation, and/or superior migration of the humeral components relative to the glenoid resulting in a rocking horse effect, fracture of the central cage, and subsequent prosthesis wear.However, the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no post-operative radiographs were provided.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, FL 32653 ; 3525541928
• MDR Report Key: 22671527
• Report Number: 1038671-2025-02644
• Device Sequence Number: 3702569
• Product Code: KWS
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/10/2025

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: 02/28/2022
• Device Catalogue Number: 314-13-34
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: Male