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 Code	Metal Related Pathology (4530)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the revision reported was likely the result of fracture of the polyethylene center and superior pegs from the glenoid body leading to glenoid wear and migration, as well as abnormal articulation between the humeral head and retained center cage.It is unclear if the reported humeral loosening was a contributing factor to the event.However, the humeral loosening and series of events cannot be confirmed as the devices were not returned for evaluation and no initial post-operative radiographs were provided.D10: 300-10-45 - equinoxe replicator plate 4.5mm o/s 300-20-02 - equinox square torque define screw drive kit.
Event or Problem Description
As reported, approximately 5 years post the initial right total shoulder arthroplasty, the patient was revised.One peg and cage also dissociated and were removed.Metallosis was seen, most likely due to the pegs/cage being exposed to the head.The stem was loose as well.Explanted all hardware and revised to an antibiotic spacer.All parts/pieces were removed from the patient.There was a 45 minute surgical delay, but no adverse events as a result.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22554554
• Report Number: 1038671-2025-02522
• Device Sequence Number: 9529032
• Product Code: KWS
• UDI-Device Identifier: 10885862083869
• UDI-Public: 10885862083869
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 07/21/2025

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: 01/30/2024
• Initial Report FDA Received Date: 07/21/2025
• 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: 64 YR
• Patient Sex: Female