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

Model Number	314-13-24
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s):300-10-15, 6529693 - equinoxe replicator plate 1.5mm o/s.300-20-02, 6606691 - equinox square torque define screw drive kit.310-01-47, 6511341 - equinoxe, humeral head short, 47mm (beta).
Event or Problem Description
Approximately 10 months postop the initial l tsa, the (b)(6) y/o male patient was experiencing pain and discomfort in l shoulder and was converted from an anatomic total shoulder to a reverse shoulder.All anatomic components, with the exception of the humeral stem, were explanted.The stem remained intact and a reverse shoulder was implanted using the current stem.Pt was revised to a 42mm +4 offset glenosphere, +0 adapter tray, sup/post augmented baseplate (left) and 42mm +0 humeral liner.Patient was last known to be in stable condition following the event.Devices are not returning due to facility policy.
Additional 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
• Common Device Name: CAGE GLENOID L, POST AUG, LEFT
• MDR Report Key: 12303196
• Report Number: 1038671-2021-00378
• Device Sequence Number: 14372941
• Product Code: KWT
• UDI-Device Identifier: 10885862200983
• UDI-Public: 10885862200983
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2024
• Device Model Number: 314-13-24
• Device Catalogue Number: 314-13-24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR