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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that a patient, initial right shoulder implanted on an unknown date, underwent a revision procedure on (b)(6), 2024.All exactech shoulder components were removed due to infection.This included an hrp construct, humeral tray/liner, as well as reverse glenoid components.No new devices were implanted.The patient will likely be revised to exactech devices in the future.There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as it is against hospital policy.No device images were provided.No further information.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18852007
• MDR Text Key: 337070770
• Report Number: 1038671-2024-00412
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention