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 Bacterial Infection (1735)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 320-10-10 - equinoxe reverse tray adapter plate tray +10: 5232147.320-02-42 - rs expanded glenosphere 42mm, +4mm offset: 5645362.320-15-05 - eq rev locking screw: 5600768.320-20-00 - eq reverse torque defining screw kit: 5667604.(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the patient had a left tsa on (b)(6) 2019 and presented with deep infection, on (b)(6) 2022.Patient was seen on (b)(6) 2022.Describes significant pain shoulder while attempting to lift a 50lbs.Bag 6 weeks prior to visit.Work up w/ ct indicated rct.Revision was recommended to convert to rtsa.Patient delayed surgery for over a year.Intra-op findings showed an intact rc.Significant synovitis was encountered, and a deep infection was suspected.A stage revision was carried out by placing a spacer.The outcome of this event is considered resolved on (b)(6) 2024.The action taken was revision on with the removal of the standard humeral stem, replicator plate, torque screw, humeral head, glenoid.The case report form indicates that this event is possibly 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: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18861547
• MDR Text Key: 337185870
• Report Number: 1038671-2024-00432
• 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: 03/07/2024

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: 02/06/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2018
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White