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

Model Number 300-62-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 310-62-50, 6463624 - stemless humeral head 50mm x 16mm x beta.

Event 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.

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: STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3
• MDR Report Key: 12545727
• MDR Text Key: 273740597
• Report Number: 1038671-2021-00500
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862536761
• UDI-Public: 10885862536761
• Combination Product (y/n): N
• PMA/PMN Number: K173388
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-62-03
• Device Catalogue Number: 300-62-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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
• Patient Age: 71 YR