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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

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

Patient Problem Joint Dislocation (2374)

Event Date 12/07/2022

Event Type  Injury  

Event Description

As reported, approximately two years post initial left tsa, the 81 y/o female patient had revision due to dislocation.Patient revised to exactech implant with a liner changed.There was no breakage of device and there was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays and photos.The device is not available for evaluation as they were disposed by the hospital.No additional information.

Manufacturer Narrative

As reported, an 82 yo female patient experienced a left reverse shoulder revision.The patient was revised due to dislocation, the liner was exchanged.The revision procedure is not related to breakage of device & did not lead to surgical delay/prolongation.The patient was last known to be in stable condition following the event.The devices are not returning; disposed of by hospital.No additional information.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 shoulder dislocation and revision surgery cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Dislocation is a known device specific risk.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE 38MM 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: 16070947
• MDR Text Key: 306362216
• Report Number: 1038671-2022-01644
• Device Sequence Number: 1
• Product Code: KWT
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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 LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2020
• 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 LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOXE REVERSE 38MM GLENOSPHERE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; EQUINOXE, HUMERAL PRIMARY, PRESS FIT 9MM; RS GLENOID PLATE POST AUG, 8 DEG, LEFT
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female