MAUDE Adverse Event Report: EQUINOXE; STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3

Model Number	300-62-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 310-62-50, 6463624 - stemless humeral head 50mm x 16mm x beta.
Event or Problem Description
As reported, approximately 3 mos postop the initial ltsa, this (b)(6) y/o male patient had a failed glenoid that had been removed arthroscopically.Now, approximately 3 mos later, the patient had continued pain and opted for a full revision.A stemless shoulder was removed, and a reverse was put in its place.Patient was last known to be in stable condition following the event.Devices will not return due to hospital policy.Associated with 1038671-2021-00332.
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: STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3
• MDR Report Key: 12545727
• Report Number: 1038671-2021-00500
• Device Sequence Number: 14437563
• Product Code: KWT
• UDI-Device Identifier: 10885862536761
• UDI-Public: 10885862536761
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 300-62-03
• Device Catalogue Number: 300-62-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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: 71 YR