MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-11
Medical Device Problem Codes	Separation Failure (2547); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient previously underwent a left shoulder replacement and subsequently required a revision surgery to address pain.Based on provided radiograph, the glenoid components are seen to be no longer be fixed within the bone and appear to have rotated.The surgeon¿s plan for the revision procedure was to remove the glenosphere, recut the humerus, and implant new humeral components.During the procedure, the surgeon removed the fixed-angle torque screw and attempted to remove the humeral adapter tray; however, the stem disengaged and was removed with the tray still attached.Attention was then turned to the glenosphere.After removal of the locking screw, the surgeon attempted to disengage the glenosphere from the baseplate using manual manipulation.Additional attempts were made, however, the glenosphere and baseplate were ultimately removed together as a single construct.The surgeon removed all the implants and made a homemade spacer as a first stage revision procedure.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: katy priest ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25299690
• Report Number: 1038671-2026-00649
• Device Sequence Number: 13087984
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/27/2026

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: 300-01-11
• 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: 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 11/26/2025
• 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: 81 YR
• Patient Sex: Male