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

Model Number EQUINOXE REVERSE 42MM GLENOSPHERE

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

Patient Problem Pain (1994)

Event Date 11/30/2023

Event Type  Injury  

Event Description

As reported, approximately four years post initial right tsa, the 75 y/o male patient complained of pain and poly failure.Patient was not revised to exactech devices.There was no breakage of device or surgical delay/prolongation reported.Patient last known to be in stable condition following the event.Images received.The device is not available for evaluation due to hospital will not release due to chain of command.

Manufacturer Narrative

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

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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: miguel soza
• MDR Report Key: 18395070
• MDR Text Key: 331344565
• Report Number: 1038671-2023-03053
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• 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 COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (3); EQ REV LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOXE REVERSE 42MM HUMERAL LINER +2.5; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; EQUINOXE, HUMERAL STEM PRIMARY; GLND KWIRE; RS GLENOID PLATE SUP AUG, 10 DEG
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male