MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Septic loosening (4884)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 320-02-38 - rs expanded glenosphere 38mm, +4mm offset, (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6) 320-15-02 - rs glenoid plate sup aug, 10 deg, (b)(6) 320-15-05 - eq rev locking screw, (b)(6) 320-20-00 - eq reverse torque defining screw kit, (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0, (b)(6) 531-20-00 - shldr gps rvrs drill kit, (b)(6) 531-78-20 - shouldr gps hex pins kit.01001320009 a10012 - gps implant kit v2.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 76 yo male patient, who had a reverse shoulder implanted, underwent a revision procedure approximately 5 years 3 months post the initial procedure.The patient complained of pain.The stem was loose and may have been infected per the surgeon.The surgeon also stated the patient plays a lot of golf.There were no device breakages or surgical delays 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 due to chain of command.Device image was provided.No further information.This 1 of 2 reports for this event.

• Brand Name: EQUINOXE
• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 23000331
• Report Number: 1038671-2025-02892
• Device Sequence Number: 8997827
• Product Code: HSD
• UDI-Device Identifier: 10885862283023
• UDI-Public: 10885862283023
• 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: 2020
• 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
• Report Date (Section B): 09/08/2025

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 Catalogue Number: 300-01-14
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male