MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 9MM

Model Number	300-01-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 4 months postop the initial right tsa, this (b)(6) female patient presented with a humeral greater tuberosity fracture and was revised.Outcome is report as continuing.Patient has history of malignant melanoma and osteoarthritis.Devices are not returning due to study policy.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-38-00, equinoxe reverse 38mm humeral liner +0; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-15-06, rs glenoid plate ext cag +10mm cage peg; 320-01-38, equinoxe reverse 38mm glenosphere.
Additional Manufacturer Narrative
(h3) upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.Section h11: *the following sections have corrected information: approximately 4 months postop the initial right tsa, this 74 y/o female patient presented with a humeral greater tuberosity fracture and was revised.Outcome is report as continuing.Patient has history of malignant melanoma and osteoarthritis.Devices are not returning due to study policy.The case report form indicates this event is possibly related to devices and procedure.This event report was received through clinical data collection activities.
Event or Problem Description
Approximately 4 months postop the initial right tsa, this 74 y/o female patient presented with a humeral greater tuberosity fracture and was revised.Outcome is report as continuing.Patient has history of malignant melanoma and osteoarthritis.Devices are not returning due to study policy.The case report form indicates this event is possibly related to devices and procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 9MM
• 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: 12974808
• Report Number: 1038671-2021-00690
• Device Sequence Number: 14507219
• Product Code: KWT
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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 Model Number: 300-01-09
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White