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

Model Number UHMWPE POST AUG GLENOID LARGE, RIGHT

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

D10: concomitants: (b)(6) - 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(b)(6) - 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6) - 300-20-02 - equinox square torque define screw drive kit.(b)(6) - 310-02-50 - equinoxe, humeral head tall, 50mm (beta).(b)(6) - 314-02-34 - uhmwpe post aug glenoid large, right.(b)(6) - 315-35-00 - glnd kwire.(b)(6) - 315-35-00 - glnd kwire.

Event Description

It was reported that a male patient, initial shoulder implanted on (b)(6) 2012, underwent a revision procedure on (b)(6) 2024, approximately 11 years 9 months post the initial procedure.The patient was converted from an anatomic to a reverse with a competitor¿s custom glenoid.Exactech tray and liner was implanted with the existing stem.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.No explanted devices are available for return.The hospital kept them.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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19160960
• MDR Text Key: 340801614
• Report Number: 1038671-2024-00940
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862175113
• UDI-Public: 10885862175113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103419
• 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

• 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: 02/09/2016
• Device Model Number: UHMWPE POST AUG GLENOID LARGE, RIGHT
• Device Catalogue Number: 314-02-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2024
• Date Device Manufactured: 02/10/2011
• 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