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

Model Number EQUINOXE REVERSE 38MM GLENOSPHERE

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

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that a 65 yo male patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient was revised due to infection.The glenosphere, liner and adapter tray were revised.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.The explanted devices are not available for analysis as they were disposed of by the hospital.No further information.

Manufacturer Narrative

D10: concomitants: (b)(6)- 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.(b)(6)- 315-35-00 - glnd kwire.(b)(6)- 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6)- 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6)- 320-15-03 - rs glenoid plate post aug, 8 deg, left.(b)(6)- 320-15-05 - eq rev locking screw.(b)(6)- 320-20-00 - eq reverse torque defining screw kit.(b)(6)- 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6)- 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6)- 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6)- 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6)- 320-38-00 - equinoxe reverse 38mm humeral liner +0.(b)(6)- 31-20-00 - shldr gps rvrs drill kit.(b)(6)- 531-78-20 - shouldr gps hex pins kit.4000523050 ¿ (b)(6)- gps implant kit v2.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
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18735570
• MDR Text Key: 335716004
• Report Number: 1038671-2024-00256
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Date Device Manufactured: 06/29/2023
• 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: 65 YR
• Patient Sex: Male