MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-13-32

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that this female patient's right shoulder was revised 5 years 10 months post op initial surgery.Surgeon voiced his concerns about the glenoid to (b)(6) after a anatomic to reverse revision surgery and after he found out about a recall.Glenoid was revised to competitors device.Patient was last known to be in stable condition following the event.Devices are not returning, hospital kept.

Manufacturer Narrative

Section h10: (h3) pending evaluation: (d10) concomitant device(s): ab0646 - 13a2101 - cemex system fast genta 70g, ab0991 - 13a2111 - cemex system fast genta 40g, 1896962 - 300-01-07 - equinoxe, humeral stem primary, press fit 7mm, 5093274 - 300-01-09 - equinoxe, humeral stem primary, press fit 9mm, 5128477 300-20-02 - equinox square torque define screw drive kit, 5182909 - 300-20-02 - equinox square torque define screw drive kit, 5151345 - 300-50-45 - 4.5mm short rep plate, 5028015 - 310-01-47 - equinoxe, humeral head short, 47mm (beta), 4250976 - 314-13-32 - equinoxe cage glenoid s, post aug, right, 8012017045 - a10012 - gps implant kit v2, ab0898r - cnl-09 - small cement cannula.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• 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: 19203914
• MDR Text Key: 341360935
• Report Number: 1038671-2024-01005
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Catalogue Number: 314-13-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2016
• 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 Outcome(s): Required Intervention
• Patient Sex: Female