MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 9999

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

(d10) concomitant device(s): 320-42-00 - equinoxe reverse 42mm humeral liner +0 : 4419017.320-01-42 - equinoxe reverse 42mm glenosphere : 4816614.320-10-00 - equinoxe reverse tray adapter plate tray +0 : 4808693.320-15-05 - eq rev locking screw : 4583012.320-15-06 - rs glenoid plate ext cag +10mm cage peg : 4790245.320-20-00 - eq reverse torque defining screw kit : 4762998.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm : 4703089.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : 4702786.

Event Description

As reported by the equinoxe shoulder study, the 52-year-old male had a right tsa on 04-07-2017.The patient present with aseptic humeral loosening on 01-30-2024.It was reported that pain worsened since forced movement in october 2023, and known metaphyseal osteolysis.Ct-scan show rll zone 6,7.This case is related to (b)(4).The patient underwent the action of standard reverse revision surgery on 02-21-2024.The outcome of this event is considered resolved.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE HUMERAL STEM
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19131044
• MDR Text Key: 340447608
• Report Number: 1038671-2024-00896
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2016
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 82 KG