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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/20/2024

Event Type  Injury  

Event Description

As reported, approximately four months post right tsa, the 58 y/o male female patient had a first stage removal of an exactech reverse shoulder due to infection.An antibiotic spacer was implanted after all implants were removed.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 not available for evaluation as they were disposed at hospital.

Manufacturer Narrative

Section d10: concomitant products: - rs expanded glenosphere 38mm, +4mm offset (cat# 320-02-38 / serial# (b)(6).- equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(6).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6).- equinoxe reverse 38mm humeral const liner +0 (cat# 320-38-10 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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: 18919053
• MDR Text Key: 337843488
• Report Number: 1038671-2024-00531
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• 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 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: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2021
• 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: 58 YR
• Patient Sex: Female