MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: equinoxe reverse 46mm glenosphere (cat# 320-01-46 / serial# (b)(6).145-deg pe 46mm const hum liner +0 (cat# 320-46-10 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by equinoxe shoulder study, approximately three years post initial right tsa, the 71 y/o male patient experienced disassociation of humeral plate.Patient had been lifting heavy buckets on his farm repetitively then felt a pop and experienced pain immediately.The patient had a revision on (b)(6) 2024.Per clinical study report, the reported event is definitely related to the device and to the procedure.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +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: michael crader
• MDR Report Key: 18989468
• MDR Text Key: 338739836
• Report Number: 1038671-2024-00682
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2020
• 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 SHOULDER DRILL KIT
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White