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

Model Number	314-13-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-10-15, 4895031 - equinoxe replicator plate 1.5mm o/s.300-20-02, 4424373 - equinox square torque define screw drive kit.310-02-47, 4070895 - equinoxe, humeral head tall, 47mm (beta).
Event or Problem Description
As reported, approximately 4 yrs postop the initial right tsa, this (b)(6) y/o male patient¿s shoulder was revised.The cage had separated from the poly.He removed the head, replicator plate, screw, and the glenoid.Stem stayed.He grafted the glenoid and left it.He then replaced the plate and head, leaving it a hemi.No broken parts were left behind.Patient was last known to be in stable condition following the event.Devices to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of failure of the cage glenoid component.Possible contributing factors include but are not limited to incomplete or off-axis seating of the glenoid component at the time of implantation, patient conditions (i.E.Poor bone quality), and/or a post traumatic event.The root cause of the failure cannot be determined from the information provided because the cage glenoid was not provided for evaluation.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 4 yrs postop the initial right tsa, this 63 y/o male patient¿s shoulder was revised.The cage had separated from the poly.He removed the head, replicator plate, screw, and the glenoid.Stem stayed.He grafted the glenoid and left it.He then replaced the plate and head, leaving it a hemi.No broken parts were left behind.Patient was last known to be in stable condition following the event.Devices will not be returning, rep was not able to retrieve them.(h6) component code: 4720, anchor.
Event or Problem Description
As reported, approximately 4 yrs postop the initial right tsa, this 63 y/o male patient¿s shoulder was revised.The cage had separated from the poly.He removed the head, replicator plate, screw, and the glenoid.Stem stayed.He grafted the glenoid and left it.He then replaced the plate and head, leaving it a hemi.No broken parts were left behind.Patient was last known to be in stable condition following the event.Devices will not be returning, rep was not able to retrieve them.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID LARGE, BETA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12405960
• Report Number: 1038671-2021-00458
• Device Sequence Number: 14519097
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 04/25/2021
• Device Model Number: 314-13-14
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG