MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-15
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: ((b)(6)) 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.((b)(6)) 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.((b)(6)) 320-01-42 - equinoxe reverse 42mm glenosphere.((b)(6)) 320-15-04 - rs glenoid plate r post aug, 8 deg, right.((b)(6)) 320-15-05 - eq rev locking screw.((b)(6)) 320-10-00 - equinoxe reverse tray adapter plate tray +0.((b)(6)) 320-20-00 - eq reverse torque defining screw kit.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-01203, 1038671-2025-02086, 1038671-2025-02088.If no device return, but images, radiographs, and/or op notes received for investigation: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported approximately 43 months post right total shoulder arthroplasty; the patient underwent a revision procedure.Intraoperatively, the surgeon observed the polyethylene component was disassembled, causing the tray and sphere to articulate to the point of wearing through the tray causing metallosis.It was noted that the parts, pieces and fragments were removed from the patient's wound site.There were no medical or surgical interventions reported.There were no medical or operative reports provided.Post operative photos were provided.The patient was last known to be in stable condition following the event.No additional information is available.
Additional Manufacturer Narrative
H3: the revision reported was likely due to disassembly between the humeral liner and humeral tray, leading to subsequent metal-on-metal articulation between unintended components and resulting prosthesis wear.Potential contributions of user and patient-related considerations, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly and prosthesis wear cannot be determined as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• 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, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22044924
• Report Number: 1038671-2025-02091
• Device Sequence Number: 18338213
• Product Code: HSD
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 06/24/2025

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: 300-01-15
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male