MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	314-13-03
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
I had a right shoulder replacement on (b)(6) 2020.Around the fall of 2022, i started to experience pain in my right shoulder and right arm.Gradually, the pain worsened, and i contacted the orthopedic surgeon who did the replacement in early 2023.I could feel and hear grinding in my shoulder with movement, and was concerned something was wrong.I had imaging done via my orthopedic surgeon, and was told the screws looked like they had loosened.I completed 2 months of therapy, with no relief.After repeat imaging later on in 2023, he told me that it looked like the glenoid part of my replacement failed.I was given options, all including different surgeries.I chose to have the failed, fractured portion removed only surgically (b)(6) 2024.During the surgery, it was discovered that prosthetic socket was fractured, with all 5 screws loose, and that the inside of my shoulder joint was black from the grinding of the prosthesis and the screws.Unfortunately, 3 of the screws floated into my tissues and were unable to be safely removed because of their location to nerves.Because of this, i lost over a year of quality of life, as i am right-hand dominant and was unable to complete simple tasks like opening car doors, dressing without pain, house chores, etc.Since the removal of the failed glenoid prosthesis, my pain has improved, but i continue to have pain to this day and i am still completing physical therapy, amongst follow-up visits with my orthopedic surgeon.

• Brand Name: EQUINOXE CAGE GLENOID
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 18977533
• Report Number: MW5153121
• Device Sequence Number: 15072712
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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?: No
• Device Model Number: 314-13-03
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown