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

Model Number HUMERAL LINER, 40MM, +0

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Dislocation (2374)

Event Date 02/17/2023

Event Type  Injury  

Event Description

It was reported via a clinical study, ¿equinoxe shoulder study¿, that a 55 yo female patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient dislocated their left shoulder anteriorly/inferiorly on (b)(6) 2023, with no injury reported, and underwent revision due to an acute inferior dislocation.The humeral liner was revised.The study indicates the event was definitely not related to the device or the procedure.The event was resolved on (b)(6) 2023.No further details.

Manufacturer Narrative

D10: concomitants:5.6969622 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.A280070 320-31-40 - glenosphere, 40mm.A314350 320-10-00 - equinoxe reverse tray adapter plate tray +0.A316194 320-35-01 - small glenoid plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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 sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18692367
• MDR Text Key: 335185929
• Report Number: 1038671-2023-02618
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HUMERAL LINER, 40MM, +0
• Device Catalogue Number: 320-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White