MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-42-00

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

Patient Problem Failure of Implant (1924)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that a patient, who had an initial total right shoulder replacement on (b)(6) 2021, underwent a revision procedure on (b)(6) 2023, approximately 2 years 8 months post the initial procedure.Patient was revised due to pain.Patient was revised to a 42mm humeral liner.Reported event is not related to breakage of device.There was no surgical delay or prolongation.Patient was last known to be in stable condition following the event.Images were provided.No device returns available due to hospital¿s chain of command.No further information.

Manufacturer Narrative

H3: pending investigation.D10: concomitants: (b)(6), 300-01-14 - equinoxe humeral stem primary press fit 14mm; (b)(6), 320-06-42 - glenosphere 42mm; (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-04 - rs glenoid plate r post aug, 8 deg, right; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (b)(6), 531-78-20 - shouldr gps hex pins kit.

• Brand Name: EQUINOXE REVERSE 42MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18374729
• MDR Text Key: 331184556
• Report Number: 1038671-2023-03048
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2021
• 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: SEE H10
• Patient Age: 73 YR
• Patient Sex: Male