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

Catalog Number 300-01-07

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): a673379 320-36-00 - 145-deg pe 36mm hum liner +0.A661705 320-35-02 - small superior augment glenoid plate.A711745 320-10-00 - equinoxe reverse tray adapter plate tray +0.A716326 320-31-36 - glenosphere, 36mm.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6) 2023.The patient presented during surgery on (b)(6) 2023 for non-displaced humeral neck fracture during reduction.The case report form indicates that this event is definitely related to device and to procedure.Outcome is resolved on (b)(6) 2023 by taking the following action: treated with cable.Devices will not be returned due to clinical study case.Due to clinical study, no devices will be returned for evaluation.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 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: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18280355
• MDR Text Key: 329887432
• Report Number: 1038671-2023-02931
• Device Sequence Number: 1
• Product Code: HSD
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2022
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White