MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10

Device Problem Misassembled (1398)

Patient Problem Failure of Implant (1924)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: - 145-deg pe 38mm hum liner +2.5 (cat# 320-38-03 / serial# (b)(6)).- eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).- eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6)).- eq rev compress screw lck cap kit, 4.5 x 30mm (cat# 320-20-30 / serial# (b)(6)).- eq rev compress screw lck cap kit, 4.5 x 30mm (cat# 320-20-30 / serial# (b)(6)).- eq rev compress screw lck cap kit, 4.5 x 34mm (cat# 320-20-34 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, 62 y/o male patient primary anatomic surgery was on (b)(6) 2014.Patient was revised and converted to a reverse on (b)(6) 2022, in which the original stem was kept.Then, about a year and a half post revision surgery, the patient came in for instability post conversion to reverse.Patient was treated with physical therapy but still had instability; therefore, the patient got a ct scan which showed tray had broken away from stem.Patient had a revision where the tray, liner and torque screw were all retained within the tray/liner construct, which was all removed from the patient.Everything that broke was removed and replaced with exactech devices.Patient was last known to be in stable condition following the event.After implants removal, it was noticed that the torque screw completely backed out of the stem, but it did not actually break as it was retained in the tray.Photos and x-rays received.The devices are not available for evaluation due to hospital kept implants.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
• 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: 18370240
• MDR Text Key: 331049334
• Report Number: 1038671-2023-03044
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086433
• UDI-Public: 10885862086433
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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 +10
• Device Catalogue Number: 320-10-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male