MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +2.5

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Date 09/28/2023

Event Type  Injury  

Event Description

It was reported that a female patient.Initial left shoulder implanted on (b)(6) 2018, underwent a revision procedure on september 28, 2023, approximately 5 years 7 months post the initial procedure.The patient had aseptic loosening of the humeral stem.The surgeon cemented in a size 10 primary humeral stem with +15 humeral tray.No device images or x-rays provided.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.The explanted devices are not available for return as the surgeon wanted them.No further information.

Manufacturer Narrative

D10: concomitants: (b)(6) 300-01-10 - equinoxe humeral stem primary press fit 10mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17926247
• MDR Text Key: 325541511
• Report Number: 1038671-2023-02523
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/12/2023
• Date Device Manufactured: 12/27/2017
• 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 Sex: Female