MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products.Equinoxe reverse 42mm glenosphere (cat# 320-01-42 / serial# (b)(6).Equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).Eq rev locking screw.(cat# 20-15-05 / serial# (b)(6).Eq reverse torque defining screw kit.(cat# 320-20-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately three months initial right tsa, the 80 y/o male patient had a revision as to the humeral stem had become loose due to a humerus fracture.The surgeon exchanged stem, glenosphere, humeral tray and liner.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sale rep was unable to obtain x-rays or images.The devices are not available for evaluation as they were discarded by the hospital.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18123238
• MDR Text Key: 328000024
• Report Number: 1038671-2023-02760
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male