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

Model Number	314-13-34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
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, RIGHT
• MDR Report Key: 12505193
• Report Number: 1038671-2021-00489
• Device Sequence Number: 3787681
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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 Model Number: 314-13-34
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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