MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL LINER, 40MM, +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 320-40-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2023

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 52-year-old non-hispanic white male had a right tsa on (b)(6) 2022.The patient present with dislocation on 01-04-2024.The patient has recurrent instability even after following a first revision case.The patient underwent a standard reverse revision surgery on (b)(6) 2024.The outcome of this event is considered resolved.The case report form indicates that this event is unlikely related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

Pending investigation.D10: 320-10-05 - equinoxe reverse tray adapter plate tray +5 : 7218469 320-32-40 - expanded glenosphere, 40mm, for small reverse : 5937774.

• Brand Name: HUMERAL LINER, 40MM, +0
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153455
• MDR Text Key: 340724621
• Report Number: 1038671-2024-00921
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182536
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/10/2020
• 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: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White