MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 300-30-06

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported by the equinoxe shoulder study that this 77 y/o female patient experienced an intra-op coracoid fracture with reduction and had a removal of a gps tracker.The case report form indicates this event is definitely related to devices or procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 320-36-03 - 145-deg pe 36mm hum liner +2.5: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).320-31-36 - glenosphere, 36mm: (b)(6).320-35-08 - small superior/posterior augglenoid plate,right: (b)(6).315-35-00 - glnd kwire: (b)(6).315-35-00 - glnd kwire: (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).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6).521-78-31 - threaded pin size 2.6 collarless 2pk, (b)(6).

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18435366
• MDR Text Key: 331867631
• Report Number: 1038671-2024-00008
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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
• Treatment: SEE H10.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White