MAUDE Adverse Event Report: EQUINOXE; CAGE GLENOID L, POST AUG, RIGHT

Model Number 314-13-34

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

Patient Problem Failure of Implant (1924)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 315-35-00, glnd kwire.300-10-45, equinoxe replicator plate 4.5mm o/s.310-01-47, equinoxe, humeral head short, 47mm (beta).300-01-13, equinoxe, humeral stem primary, press fit 13mm.

Event Description

As reported, approximately 6 yrs postop the initial tsa, this male patient was doing well and decided to shovel snow.During snow shoveling he experienced a painful incident and went to doctor.He was evaluated and a right shoulder scope was performed.After this treatment failed, he returned for a revision and conversion to a reverse.Patient was last known to be in stable condition following the event.The devices will not return due to hospital policy.

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 pain 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 L, POST AUG, RIGHT
• MDR Report Key: 12505193
• MDR Text Key: 272422503
• Report Number: 1038671-2021-00489
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• 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: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-13-34
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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