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

Model Number EQUINOXE CAGE GLENOID MEDIUM, ALPHA

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4243603 - 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.4008861 - 300-10-15 - equinoxe replicator plate 1.5mm o/s.4231975 - 300-20-02 - equinox square torque define screw drive kit.3850838 - 310-01-47 - equinoxe, humeral head short, 47mm (beta).3693572 - 14-13-03 - equinoxe cage glenoid medium, alpha.4201245 - 315-35-00 - glnd kwire.

Event Description

It was reported that a male patient, initial right shoulder implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2024, approximately 7 years 11 months post the initial procedure.The patient had a previous total shoulder replacement then failed rotator cuff which required the change to a reverse shoulder replacement.Everything was removed.Image of device provided appeared to be fractured which was reported to be found upon opening the wound site.There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.The explanted devices are not available for analysis as they were discarded at the hospital.Device images were provided.No further information.

• Brand Name: EQUINOXE
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19153877
• MDR Text Key: 340801965
• Report Number: 1038671-2024-00922
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Model Number: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2014
• 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 Sex: Male