MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY PRESS FIT 17MM

Model Number	300-01-17
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 7 years post op the initial tsa, this 51 y/o female patient's was revised to a standard reverse due to aseptic humeral loosening.Patient had periprosthetic pain, negative for infection, and surgeon planned ab spacer placement.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-01-38 - equinoxe reverse 38mm glenosphere; 320-38-00 - equinoxe reverse 38mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-01 - eq rev glenoid plate.
Additional Manufacturer Narrative
Section h10: (d4) serial number: (b)(6), expiration date: 19-jul-2023.(h3) the revision reported was likely the result of an insufficient bond between the humeral stem and the bone, patient-related conditions, or a combination of these possibilities, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were unable to be obtained.(h4) device manufacture date: 19-nov-2013 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 17MM
• 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: 14631732
• Report Number: 1038671-2022-00649
• Device Sequence Number: 14359042
• Product Code: KWT
• UDI-Device Identifier: 10885862079343
• UDI-Public: 10885862079343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 07/19/2023
• Device Model Number: 300-01-17
• Device Catalogue Number: 300-01-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 27 KG
• Patient Race: Asian