MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, BETA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE CAGE GLENOID MEDIUM, BETA

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

Patient Problem Failure of Implant (1924)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products: equinoxe, humeral head expanded, 50mm (beta) (cat#: 310-03-50 / serial#: (b)(6).Equinox square torque define screw drive kit (cat#: 300-20-02 / serial#: (b)(6).Glnd kwire (cat#: 315-35-00 / serial#: (b)(6).Equinoxe replicator plate 4.5mm o/s (cat#: 300-10-45 / serial#: (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, 62 yo 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.The surgeon mentioned that the patient disappeared or went off for a while post first revision in 2022, alluding to maybe him doing something that caused the implant to break, but nothing specific is known.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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: migule soza
• MDR Report Key: 18370184
• MDR Text Key: 331047867
• Report Number: 1038671-2023-03043
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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 Expiration Date: 08/08/2018
• Device Model Number: EQUINOXE CAGE GLENOID MEDIUM, BETA
• Device Catalogue Number: 314-13-13
• 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: 08/20/2013
• 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: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male