MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total shoulder arthroplasty.Subsequently, the patient was revised due to a fractured humerus.The surgeon replaced the glenosphere and locking screws.A competitor's stem was placed.Patient was last known to be in stable condition following the event.No further information available.
Additional Manufacturer Narrative
D10: 315-35-00 - glnd kwire (b)(6).320-01-36 - 36mm glenosphere (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-01 - eq rev glenoid plate (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (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).320-36-00 - 36mm humeral liner +0 unconstrained (b)(6).531-78-20 - shouldr gps hex pins kit (b)(6).531-78-20 - shouldr gps hex pins kit (b)(6).(b)(6) - gps implant kit v2 (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 STEM PRIMARY, PRESS FIT 9MM
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23960539
• Report Number: 1038671-2026-00006
• Device Sequence Number: 9448382
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: 300-01-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 07/15/2022
• 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 Sex: Female