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

Model Number EQUINOXE CAGE GLENOID M, POST AUG, RIGHT

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately five years post initial right tsa, the female patient had a failure of anatomic shoulder replacement.Patient had a revision of legacy caged glenoid, the central cage appeared to have disassociated from the poly.There were no fragments, parts or pieces that fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The device is not available for evaluation due to lost after case.

• Brand Name: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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
• MDR Report Key: 19169322
• MDR Text Key: 340899765
• Report Number: 1038671-2024-00957
• Device Sequence Number: 1
• Product Code: KWS
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: EQUINOXE CAGE GLENOID M, POST AUG, RIGHT
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2018
• 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: EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT.; EQUINOXE CAGE GLENOID M, POST AUG, RIGHT.; EQUINOXE REPLICATOR PLATE 1.5MM O/S.; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA).; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT.; GPS IMPLANT KIT V2.; GPS PER CASE RENTAL FEE56.; SHOULDR GPS HEX PINS KIT.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female