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

Model Number HUMERAL LINER, 40MM, +0

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 6749575 320-15-05 - eq rev locking screw.7065825 320-15-05 - eq rev locking screw.7144771 320-32-40 - expanded glenosphere, 40mm, for small reverse.7290225 321-20-00 - equinoxe reverse shoulder drill kit.

Event Description

It was reported that a 73 yo female patient, initial right shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2024, approximately 1 year 10 months post the initial procedure.Upon the revision, poly wear was noticed.The patient had a competitor¿s antibiotic spacer placed due to infection.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The explanted device is not available for analysis.It was sent to pathology at the facility.Device images were provided.No further information.

• Brand Name: EQUINOXE
• Type of Device: 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: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19074231
• MDR Text Key: 339776065
• Report Number: 1038671-2024-00768
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HUMERAL LINER, 40MM, +0
• Device Catalogue Number: 320-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Date Device Manufactured: 11/11/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female