MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-03

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

Patient Problem Bacterial Infection (1735)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): 320-06-42 - glenosphere 42mm a077815.320-10-05 - equinoxe reverse tray adapter plate tray +5 a285719.320-15-05 - eq rev locking screw a375456.320-20-00 - eq reverse torque defining screw kit a380263.

Event Description

As reported, the 56 year old male patient had an initial right tsa on (b)(6) 2018.The patient underwent a previous right side revision on (b)(6) 2023.The patient was revised again on (b)(6) 2024 due to suspected infection.The patient had a +5mm tray with a 42mm +2.5mm poly, and a 42mm glenosphere.The patients components were removed and replaced except for the baseplate and humeral stem.A 42mm +4mm lateralized glenosphere was re-implanted and a +0 tray along with a +2.5mm constrained liner.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient/medical history reported.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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 court; gainesville 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19154154
• MDR Text Key: 340736464
• Report Number: 1038671-2024-00925
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 56 YR
• Patient Sex: Male