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

Model Number	300-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-10-15, 4911806 - equinoxe replicator plate 1.5mm o/s; 310-01-44, 4835494 - equinoxe, humeral head short, 44mm (alpha); 314-13-03, 4825303 - equinoxe cage glenoid medium, alpha.
Event or Problem Description
As reported, this (b)(6) y/o male experienced a crack in calcar during implant implementation, noted as an intra-op right humeral fracture.The plan post-procedure is slow and controlled rehabilitation.The patient has a history of rheumatory arthritis, hypertension, chronic renal failure and is on dialysis.The case report form indicates this event is possibly related to devices and definitely related procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Based on review of all available information, 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 preparation for implantation of the shoulder.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10727708
• Report Number: 1038671-2020-00590
• Device Sequence Number: 13872919
• Product Code: KWT
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 300-01-13
• Device Catalogue Number: 300-01-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 68