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 Joint Dislocation (2374)

Event Date 08/28/2019

Event Type  Injury  

Event Description

As reported, approximately four months post initial right tsa, the 72 y/o male patient had a revision due to dislocation.Patient was revised to exactech devices.Liner, glenosphere and locking screw were replaced.There was no breakage of the device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation as they were disposed by hospital.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Concomitant medical products: eq rev locking screw (cat# 320-15-05 / serial# (b)(6).Equinoxe reverse 42mm glenosphere (cat# 320-01-42 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

(h3) as reported, approximately four months post initial right tsa, the 72 y/o male patient had a revision due to dislocation.Patient was revised to exactech devices.Liner, glenosphere and locking screw were replaced.There was no breakage of the device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation as they were disposed by hospital.Patient was last known to be in stable condition following the event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent closed reduction cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.

• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16898207
• MDR Text Key: 314860119
• Report Number: 1038671-2023-00952
• 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,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• 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: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• 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: EQ REV GLENOID PLATE; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male