MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number EQUINOXE PRESERVE STEM 10MM

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial left tsa on (b)(6) 2023.A coracoid fracture was noted at the time of gps tracker placement.Resolved on (b)(6) 2023 the case report form indicates this event is definitely not related to device and definitely related to procedure.This event report was received through clinical data collection activities.Outcome: resolution date: (b)(6) 2023.

Manufacturer Narrative

Pending investigation.D10: serial number.Item number and full description: (b)(6).320-06-42 - glenosphere 42mm 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-15-03 - rs glenoid plate l post aug, 8 deg, left.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17711492
• MDR Text Key: 322967960
• Report Number: 1038671-2023-02207
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: EQUINOXE PRESERVE STEM 10MM
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2022
• 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 Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White