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

Model Number EQUINOXE PRESERVE STEM 9MM

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: 6666991: 320-15-01 - eq rev glenoid plate.6929490: 321-20-00 - equinoxe reverse shoulder drill kit.6990026: 320-06-38 - glenosphere 38mm.7043614: 320-20-00 - eq reverse torque defining screw kit.7106307: 320-10-00 - equinoxe reverse tray adapter plate tray +0.7204211: 320-15-05 - eq rev locking screw.S114126: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S284269: 320-38-00 - 145-deg pe 38mm hum liner +0.S310473: 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S310808: 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S331320: 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.

Event Description

It was reported that a 73 yo female patient, who had a previous right-side revision in which her glenoid component failed due to poor bone quality, ¿she had been radiated and had poor general health¿, had underwent a second revision procedure on (b)(6) 2023.The original plan was to either revise just the glenoid if possible or convert to hemi if not.Both glenoid and humeral components were poorly fixed, so a fracture stem was cemented in as a hemi.There were no device breakages, or surgical delays reported.Unknown medical history.No x-rays were provided.The patient was in stable condition following the event.No device returns anticipated due to the hospital policy.

• 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: kate jacobson ; 3523771140
• MDR Report Key: 17167710
• MDR Text Key: 317625819
• Report Number: 1038671-2023-01408
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862515773
• UDI-Public: 10885862515773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE PRESERVE STEM 9MM
• Device Catalogue Number: 300-30-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Date Device Manufactured: 10/11/2018
• 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 Age: 73 YR
• Patient Sex: Female