MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 41MM (ALPHA); PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	310-01-41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent an initial total shoulder arthroplasty.Subsequently, the patient experienced pain and metallosis.As a result, the glenoid snapped in half and the patient was revised to a competitor's device.Patient was last known to be in stable condition following the event.No further information available.
Additional Manufacturer Narrative
D10: 300-10-15 - equinoxe replicator plate 1.5mm o/s (b)(6).300-10-45 - equinoxe replicator plate 4.5mm o/s (b)(6).300-20-02 - equinox square torque define screw drive kit (b)(6).300-30-07 - equinoxe preserve stem 7mm (b)(6).310-01-41 - equinoxe, humeral head short, 41mm (alpha) (b)(6).315-35-00 - glnd kwire (b)(6).No device was returned for evaluation; radiograph images were provided; however, the reported event was unable to be confirmed.The review identified the inferior peripheral pegs appear to have migrated from their intended positions, consistent with fracture of the glenoid component.Additionally, the center cage no longer appears parallel to the superior peripheral peg and appears that the center cage is contacting the humeral head.This appears consistent with fracture of the center cage from the glenoid body.In addition, there appears to be bone loss around the glenoid component, which may have further compromised fixation and contributed to migration of the peripheral pegs and failure of the center cage.However, the series of events cannot be confirmed as initial post-operative radiographs were not provided for evaluation.Further, the humeral head appears to be sitting proud relative to the humeral bone.According to the preserve stem operative technique, the preserve stem should be impacted until the superior face of the stem is flush with the resected humeral surface.Based on the available information, it is unclear whether the stem was initially implanted in a proud position or whether it appears proud due to observed humeral bone loss.Regardless, a proud humeral component may have further contributed to joint overstuffing, increasing eccentric loading and ultimately contributing to fracture and migration of the glenoid component.However, the sequence of events cannot be confirmed as initial post-operative radiographs were not provided.Additionally, the humeral component appears to have migrated superiorly relative to the glenoid.Post-total shoulder arthroplasty rotator cuff tearing or dysfunction is associated with proximal migration of the humeral component, which can accelerate polyethylene wear and glenoid loosening through the rocking-horse phenomenon.Although a rotator cuff deficiency was not originally reported, overstuffing of the joint is known to contribute to anatomic shoulder complications, including rotator cuff pathology, glenoid erosion, and loosening.The combination of joint overstuffing and superior humeral migration likely contributed to center cage fracture, glenoid body fracture, and subsequent migration of the glenoid component.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and no discrepancies were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, was likely associated with prosthesis wear, prosthesis fracture, and migration of the glenoid component.A combination of joint overstuffing, non-cemented use of the glenoid during implantation, and superior migration of the humeral components may have resulted in abnormal forces and eccentric loading of the glenoid, contributing to the fracture and subsequent migration.Unintended articulation between the humeral head and center cage likely resulted in the observed metal debris.However, the sequence of events cannot be confirmed, and the potential contribution of manufacturing, user, or patient-related factors could not be assessed, as the devices were not returned for evaluation and initial post-operative radiographs were 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 HEAD SHORT, 41MM (ALPHA)
• 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: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24830257
• Report Number: 1038671-2026-00407
• Device Sequence Number: 10430373
• Product Code: KWS
• UDI-Device Identifier: 10885862083869
• UDI-Public: 10885862083869
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/09/2026

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: 310-01-41
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 02/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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