MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-00

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

Patient Problem Bacterial Infection (1735)

Event Date 10/13/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 64-year-old male patient had a left tsa revision on (b)(6) 2022.The patient presented with deep infection, 0 year(s) and 1 month(s) post procedure on (b)(6) 2022.Patient was assessed for p-acnes infection during revision.Confirmed p-acnes post-op revision via intra-op cultures.Patient is on oral doxycycline hyclate post-op for at least 6weeks.Patient had continued post-op revision pain in the shoulder.Had an emg.Emg overall negative.Continued post-op revision pain.Referred for second opinion.Lov was 12/22/2022.The outcome of this event is considered continuing and the report indicates that the action taken is medication & other - nerve study.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 320-08-42 - glenosphere exp 42mm +4mm offset: a124808 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6) 320-15-05 - eq rev locking screw: a140243 320-15-06 - rs glenoid plate ext cag +10mm cage peg: 5885323 320-20-00 - eq reverse torque defining screw kit: a125090 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm: s370598 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: a061906 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: s373642 321-52-09 - 3.2mm k-wire, trocar tip: (b)(6).(h3) pending evaluation.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18877568
• MDR Text Key: 337411223
• Report Number: 1038671-2024-00454
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White