MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number	310-61-50
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Arthropathy (4894)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 58 yo male patient, who had a left primary tsa, underwent a revision to remove a stemless primary tsa and laser cage glenoid.The surgeon pointed out it was apparent that the overhang of the head implant contributed to the failure of the subscapularis.Once the head and humeral component were removed, they moved to the glenoid where the laser cage glenoid was removed with an osteotome.The central peg and inferior pegs were explanted but they were unable to remove the superior peg without causing too much damage, so it was left in.An abx shoulder spacer was reimplanted.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 head implant appears to be dislocated in the imaging.The explanted devices are not available for return.The hospital will not release them.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
D10: 300-60-03 - stemless humeral comp laser cage, size 3: (b)(6), 319-01-32 - steinmann pin sterile 3.2mm x 178mm: (b)(6), 531-78-20 - shouldr gps hex pins kit: (b)(6), (b)(6) - gps implant kit v2: 11000922065.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• 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 32653 ; 3523771140
• MDR Report Key: 24738237
• Report Number: 1038671-2026-00355
• Device Sequence Number: 14961234
• Product Code: PKC
• UDI-Device Identifier: 10885862537126
• UDI-Public: 10885862537126
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 03/31/2026

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: 310-61-50
• 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: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male