MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-08-42
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a493241 320-15-05 - eq rev locking screw, s437743 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, s440637 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, s356288 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, s409169 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, a377801 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
It was reported that approximately 12 months after a left total shoulder replacement procedure, the patient underwent a revision procedure to address pain and loosening.The surgeon removed a loose equinoxe glenoid baseplate and 42+4 glenosphere.He replaced them with a competitor¿s devices.There was no reported surgical delay or breakage of a device.Patient was last known to be in stable condition following the event.X-rays were unable to be obtained.The explanted devices are not available for return.They were sent to spd.Device images were provided.No further information.
Additional Manufacturer Narrative
Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-02364.

• Brand Name: EQUINOXE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19726545
• Report Number: 1038671-2024-02365
• Device Sequence Number: 15505786
• Product Code: PHX
• UDI-Device Identifier: 10885862563729
• UDI-Public: 10885862563729
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/01/2025

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: 320-08-42
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 72 KG