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

Catalog Number 314-13-33

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-20-02 - equinox square torque define screw drive kit.(b)(6), 300-30-08 - equinoxe preserve stem 8mm.(b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).(b)(6), 314-13-33 - equinoxe cage glenoid m, post aug, right.

Event Description

It was reported that a 78 yo male patient, initial right shoulder implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 3 months post the initial procedure.The patient had progressive deterioration of their implant.The surgeon elected to remove the implants due to implant failure which were worn over time while in situ.The patient was revised to exactech devices.During the procedure, the surgeon was able to retain the existing stem and he revised the glenoid to a reverse construct.All pieces of the implant which were worn and fragmented were removed from the patient.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are available for return, device images were provided.No further information.

• Brand Name: EQUINOXE CAGE GLENOID M, 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: 19153924
• MDR Text Key: 340790839
• Report Number: 1038671-2024-00923
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

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 Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1415-2024
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 76 KG