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

Model Number GLENOSPHERE, 36MM

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

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported a 68 yo female patient, initial right shoulder implanted on (b)(6), 2021, underwent a revision procedure on (b)(6), 2023, approximately 2 years 2 months post the initial procedure.The surgeon scheduled surgery on the patient to address shoulder pain.The surgeon indicated that he was concerned of possible infection.He intraoperatively removed all in-situ exactech humeral components and implanted a competitor¿s humeral components.The surgeon also chose to remove exactech glenoid locking screw and sphere, and at his sole discretion, chose to implant a new and identical exactech sphere and glenoid locking screw, while fully aware that this combination of a competitor¿s and exactech implants is not an fda-approved combination.No x-rays were provided.There were no surgical delays or device breakages during the procedure.The representative indicated he did not observe anything of concern with regards to patient outcome, and the surgeon did not indicate that he had any concerns with the outcome.The devices are not available for return.The hospital retains all explants-sending for cavitation.No device images provided.No further information provided.

Manufacturer Narrative

D10: concomitants: (b)(6) - 300-30-06 - equinoxe preserve stem 6mm.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(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) - 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) - 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.(b)(6) - 320-31-36 - glenosphere, 36mm.(b)(6) - 320-35-04 - small posterior augment glenoid plate, right.(b)(6) - 320-36-00 - 145-deg pe 36mm hum liner +0.(b)(6) - (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 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18597785
• MDR Text Key: 334028462
• Report Number: 1038671-2024-00134
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOSPHERE, 36MM
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2023
• Date Device Manufactured: 07/22/2021
• 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: 68 YR
• Patient Sex: Female