MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 13MM

Model Number	300-01-13
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 320-01-42, 3854482 - equinoxe reverse 42mm glenosphere.320-10-00, 4195950 - equinoxe reverse tray adapter plate tray +0.320-15-05, 4181502 - eq rev locking screw.320-20-00, 4213897 - eq reverse torque defining screw kit.320-42-03, 3912095 - equinoxe reverse 42mm humeral liner +2.5.
Event or Problem Description
As reported, approximately 6 years post op initial left tsa, this (b)(6) male patient was revised due to the stem being subsided.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.
Additional Manufacturer Narrative
The revision reported may have been the result of insufficient bony support for the implant, patient-related conditions, or a combination of these possibilities, which led to humeral stem subsidence.However, this cannot be confirmed as the devices were not returned 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: HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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: 13874422
• Report Number: 1038671-2022-00275
• Device Sequence Number: 12101891
• Product Code: KWT
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 12/02/2025
• Device Model Number: 300-01-13
• Device Catalogue Number: 300-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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: 74 YR
• Patient Sex: Male