MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-01-09

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

Patient Problem Bacterial Infection (1735)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): 320-01-42 - equinoxe reverse 42mm glenosphere: 3854530 320-10-00 - equinoxe reverse tray adapter plate tray +0: 3961684 320-15-04 - rs glenoid plate r post aug, 8 deg, right: 3936385 320-15-05 - eq rev locking screw: 3852574 320-20-00 - eq reverse torque defining screw kit: 3961185 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: 3877361 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: 3964101 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 2948571 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 3919069 320-42-00 - equinoxe reverse 42mm humeral liner +0: 3917002 321-20-00 - equinoxe reverse shoulder drill kit: 3933780.

Event Description

As reported by the equinoxe shoulder study, the 44 year old male patient had an initial right tsa on (b)(6) 2015 and presented with infection, 2 year(s) and 1 month(s) post initial procedure on (b)(6) 2017.The case report form indicates that this event is unlikely related to the device and possibly related to the procedure.The report also indicates that the no was action taken and the outcome of this event is unknown.No device return anticipated due to being a clinical trial study.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• 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: 18726849
• MDR Text Key: 335620902
• Report Number: 1038671-2024-00251
• 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: 02/16/2024

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: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2015
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 127 KG
• Patient Ethnicity: Hispanic