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

Model Number	314-13-14
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during removal, the surgeon found the patient left shoulder implant to be damaged.The glenoid was missing a chunk.Surgeon only removed the glenoid from the patient.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device will not be retuning, surgeon kept implant.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the cause of the revision reported cannot be determined from the information provided, but may have been related to the cage glenoid component, which was reportedly found to be ¿missing a chunk¿ during the revision surgery.It is unclear if the glenoid was excessively worn, the polyethylene fractured, or if the cage/peripheral pegs disassociated from the polyethylene body.The exact events and order of events cannot be confirmed because no images of the explanted device or radiographs were provided and the revised component was not returned to exactech for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• 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: 14082956
• Report Number: 1038671-2022-00413
• Device Sequence Number: 19366730
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 10/18/2020
• Device Model Number: 314-13-14
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown