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

Model Number HUMERAL LINER, 40MM, +2.5

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: a798874 - 300-01-11 - equinoxe, humeral stem primary, press fit 11mm 7232012 -320-10-05 - equinoxe reverse tray adapter plate tray +5 a566398 - 320-20-00 - eq reverse torque defining screw kit additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 72 yo female patient, initial right shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2024, approximately 2 months post the initial procedure.The patient was revised due to infection.The surgeon performed a washout and replaced the liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.The rep was unable to obtain any device images or x-rays.The explanted device is not available for return as it was disposed of by the hospital.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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18882554
• MDR Text Key: 337414932
• Report Number: 1038671-2024-00465
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HUMERAL LINER, 40MM, +2.5
• Device Catalogue Number: 320-40-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 05/14/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Female