MAUDE Adverse Event Report: EQUINOXE; CAGE GLENOID LARGE, BETA

Model Number	314-13-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 300-20-00, (b)(4) - equinoxe torque defining replaced by 320-20-02.300-10-15, (b)(4) - equinoxe replicator plate 1.5mm o/s.300-20-02, (b)(4) - equinox square torque define screw drive kit.310-01-50, (b)(4) - equinoxe humeral head short, 50mm (beta).
Event or Problem Description
As reported, approximately 2.5 yr postop the initial rtsa, the male patient had the right loose glenoid component removed along with the humeral head and replicator plate to get to the glenoid.Bone graft was used to fill holes on the glenoid.The surgeon also used a new replicator plate and head and left the shoulder as a hemi.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the device was not returned for evaluation.Section h11: *the following sections have corrected information: (section f) please disregard f10, health effect - impact code.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID LARGE, BETA
• MDR Report Key: 12312951
• Report Number: 1038671-2021-00383
• Device Sequence Number: 3165275
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 04/01/2023
• Device Model Number: 314-13-14
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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