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

Model Number	300-01-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-36-00 - 36mm humeral liner +0 unconstrained.320-10-00 - equinoxe reverse tray adapter plate tray +0.Reverse humeral tray (extension).320-31-36 - glenosphere, 36mm.320-35-02 - small superior augment glenoid plate.
Event or Problem Description
As reported, during the initial procedure for this 61 y/o female, when placing the right final stem, due to the hard diaphyseal bone, there was a periprosthetic fracture that did extend past the metaphysis.The stem was still stable.The area of the fracture was packed with humeral head autograft and a single cerclage cable was placed.The case reports state the issue was resolved on (b)(6) 2021.The case report form indicates this event is not related to devices and possibly related to procedure.This event report was received through clinical data collection activities.Devices remain implanted.Patient has a history of osteonecrosis, adrenal insufficiency, hypotension, hypothyroidism, status post chemotherapy, and received subacromial injection (b)(6) 2020, (b)(6) 2020, at an outside institution.
Additional Manufacturer Narrative
(h3) based on review of all available information and considering the report that the patient has hard diaphyseal bone, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the reported event was a fracture which was likely caused during implantation of the shoulder.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12083217
• Report Number: 1038671-2021-00317
• Device Sequence Number: 3348235
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 49