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 Unspecified Infection (1930)

Event Date 02/22/2024

Event Type  Injury  

Event Description

As reported, approximately one year post initial right tsa, the 59 y/o male patient presented with an infection.The equinoxe reverse was taken out and an antibiotic spacer was put back in.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are no available for evaluation due to they were discarded.

Manufacturer Narrative

Section d10: concomitant products - equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).- eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6).- eq rev compress screw lck cap kit, 4.5 x 34mm (cat# 320-20-34 / serial# (b)(6).- eq rev glenoid plate (cat# 320-15-01 / serial# (b)(6).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6).- equinoxe reverse 42mm glenosphere (ca# 320-01-42 / serial# (b)(6).- equinoxe, humeral stem primary, press fit 13mm (cat# 300-01-13 / serial#(b)(6).- eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6).- eq rev locking screw (cat# 320-15-05 / 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: michael crader
• MDR Report Key: 18919052
• MDR Text Key: 337843433
• Report Number: 1038671-2024-00530
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• 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: 59 YR
• Patient Sex: Male