MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL LONG STEM 10MM 200MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	306-02-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Sepsis (2067)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 322-42-10 - 145-deg pe 42mm const hum liner +0: (b)(6), 320-42-00 - humeral liner, 322-10-00 - humeral adapter tray, +0: (b)(6), 320-06-42 - glenosphere 42mm: (b)(6), 320-15-01 -reverse glenosphere baseplate , 320-15-05 - eq rev locking screw: (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.
Event or Problem Description
It was reported via a clinical study that the patient underwent a shoulder arthroplasty.Subsequently, the patient developed humeral loosening with an associated osteolytic fracture involving the greater tuberosity.There is also a potential underlying infection (sepsis).The surgeon performed a revision procedure during which the following components were removed: humeral stem, torque screw, humeral tray, humeral liner, glenosphere, and locking screw.At this time, the outcome is considered resolved.No further information is available.

• Brand Name: EQUINOXE HUMERAL LONG STEM 10MM 200MM
• 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: ashley harris ; 2320 nw 66 ct; gainesville, FL ; 3523771140
• MDR Report Key: 24654345
• Report Number: 1038671-2026-00307
• Device Sequence Number: 6109978
• Product Code: HSD
• UDI-Device Identifier: 10885862083807
• UDI-Public: 10885862083807
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K061454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 306-02-10
• 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: 02/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 03/01/2023
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 94 KG