MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	310-01-50
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 7 years after initial left tsa, the patient was revised due to failure of the cage glenoid, the pegs had dissociated from the poly.The patient had osteolysis, signs of metallosis and significant bone loss.The patient was not revised to exactech devices.The patient was revised to a djo glenoid and exactech humeral components.The event is not related to the breakage of a device.The event did no lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays provided.Product not returning due to hospital policy.
Additional Manufacturer Narrative
D10: concomitants: 4750074 300-01-12 - equinoxe humeral stem primary press fit 12mm, 4667555 300-10-45 - equinoxe replicator plate 4.5mm o/s, 4660143 300-20-02 - equinox square torque define screw drive kit.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of prosthesis wear of the polyethylene glenoid body.The wear through the glenoid body may have led to metal-on-metal prosthesis wear between the humeral head and retained center cage resulting in metallosis in the surrounding tissue.However, prosthesis wear of the metal components could not be confirmed as the devices were not returned for evaluation.Contributing factors to the glenoid failure could have been improper initial seating of the glenoid body during implantation resulting in eccentric loading; however, these and any other potential contributions of user and patient-related considerations to the event could not be assessed from the provided information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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 32653 ; 3525541928
• MDR Report Key: 19716074
• Report Number: 1038671-2024-02349
• Device Sequence Number: 15526462
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 05/31/2026
• Device Catalogue Number: 310-01-50
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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: 84 YR
• Patient Sex: Male