MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 7MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-30-07

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Pending evaluation (d10) concomitant device(s): 320-42-03 - equinoxe reverse 42mm humeral liner +2.5 320-10-00 - equinoxe reverse tray adapter plate tray +0 320-01-42 - equinoxe reverse 42mm glenosphere 320-15-01 - eq rev glenoid plate.

Event Description

As reported by the equinoxe shoulder study, the 71-year-old male patient had an initial right tsa on 12-dec-2020 and presented with bone fracture, 3 year(s) and 10 month(s) post initial procedure on (b)(6) 2023.The case report form indicates that this event is possibly related to the device and unlikely related to the procedure.The report also indicates that the action taken is considering open reduction internal fixation of fracture.The outcome of this event is continuing.No device return anticipated due to being a clinical trial study.

• Brand Name: EQUINOXE PRESERVE STEM 7MM
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18727089
• MDR Text Key: 335696406
• Report Number: 1038671-2024-00252
• Device Sequence Number: 1
• Product Code: HSD
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White