MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately 3.5 years post initial left tsa, the 72 y/o male patient experienced poly disassociation.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• 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: matt collins
• MDR Report Key: 19033645
• MDR Text Key: 339261376
• Report Number: 1038671-2024-00724
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2020
• 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 COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOXE PRESERVE STEM 7MM; EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; EQUINOXE REVERSE SHOULDER DRILL KIT; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; GLENOSPHERE 42MM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male