MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-01-13

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 320-42-00 - 145-deg pe 42mm hum liner +0 : s488248.320-06-42 - glenosphere 42mm : a624316.320-10-00 - equinoxe reverse tray adapter plate tray +0 : a838845.320-15-02 - rs glenoid plate sup aug, 10 deg : a826171.320-15-05 - eq rev locking screw : a884012.320-20-00 - eq reverse torque defining screw kit : a835860.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm : s482734.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s509613.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s512807.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm : s501818.531-55-88 - ergo gps 3.2mm drill kit sterile : a788969.531-78-20 - shouldr gps hex pins kit : a766918 (h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 79-year-old non-hispanic white male had a right tsa on (b)(6) 2024.Intra-operatively on (b)(6) 2024, patient experience a calcar split while impacting humeral stem.The patient underwent the action of 2.0 beaded cable on (b)(6) 2024 and the outcome of this event is considered to be resolved.The case report form indicates that this event is definitely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19093744
• MDR Text Key: 339983556
• Report Number: 1038671-2024-00809
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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 Catalogue Number: 300-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 131 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White