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	Pain (1994); Metal Related Pathology (4530)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-15 - equinoxe, humeral stem primary, press fit 15mm; sn# (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s; sn# (b)(6), 300-20-02 - equinox square torque define screw drive kit; sn# (b)(6), 314-13-34 equinoxe cage glenoid l, post aug, right; sn# (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial anatomic shoulder replacement on the right side.Subsequently, the patient experienced pain secondary to poly disassociation.As a result, approximately seven years and seven months post-surgery, the patient underwent a revision.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.This is report 2 of 2 for this event/patient.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22420903
• Report Number: 1038671-2025-02430
• Device Sequence Number: 8761036
• Product Code: HSD
• UDI-Device Identifier: 10885862083890
• UDI-Public: 10885862083890
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2025
• 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): 10/08/2025

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: 03/31/2026
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male