MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant product: eq rev torque screw kit (cat# 320-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately 2.5 years post initial left tsa, the 67 y/o male patient had a revision due to poly disassociated.The patient was revised to upsized humeral tray and liner.The patient is stable.There was no breakage the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images/x-rays.The devices are not available for evaluation due to hospital policy.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL CONST 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: 18946700
• MDR Text Key: 338185060
• Report Number: 1038671-2024-00601
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0
• Device Catalogue Number: 320-38-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male