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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +0

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

Patient Problem Bacterial Infection (1735)

Event Date 01/05/2024

Event Type  Injury  

Event Description

As reported, approximately fourteen days post initial right tsa, the 82 y/o female patient had a revision due to infection that it developed after surgery.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices are not available for evaluation due to hospital policy.

Manufacturer Narrative

Section d10: concomitant products: - eq humeral stem 14mm (cat# 300-01-14 / serial# (b)(6) ); - eq glenosphere 42mm +4 (cat# 320-08-42 / serial# (b)(6) ); - eq adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6) ); - eq rev locking screw (cat# 320-15-05 / serial# (b)(6) ); - sup/post aug plate r rs glenoid (cat# 320-15-08 / serial# (b)(6) ); - eq rev torque screw kit (cat# 320-20-00 / serial# (b)(6) ); - eq rev compression screw 26mm (cat# 320-20-26 / serial# (b)(6) ); - eq rev compression screw 26mm (cat# 320-20-26 / serial# (b)(6) ).- eq rev compression screw 30mm (cat# 320-20-30 / serial# a832176) - eq rev compression screw 38mm (cat# 320-20-38 / serial# (b)(6) ).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18652136
• MDR Text Key: 334680566
• Report Number: 1038671-2024-00166
• Device Sequence Number: 1
• Product Code: KWT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +0
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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: 82 YR
• Patient Sex: Female