MAUDE Adverse Event Report: EQUINOXE; CAGE GLENOID MEDIUM, ALPHA

Model Number 314-13-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation: concomitant device(s): 300-20-02, (b)(4) - equinox square torque define screw drive kit.310-01-44, (b)(4) - equinoxe, humeral head short, 44mm (alpha).300-01-09, (b)(4) - equinoxe, humeral stem primary, press fit 9mm.300-10-45, (b)(4) - equinoxe replicator plate 4.5mm o/s.

Event Description

As reported, approximately 3 years postop the initial ltsa, this female patient was revised for instability.Patient was last known to be in stable condition following the event.Devices were disposed by the facility.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID MEDIUM, ALPHA
• MDR Report Key: 12539503
• MDR Text Key: 273541370
• Report Number: 1038671-2021-00495
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: 314-13-03
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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): Hospitalization; Required Intervention