MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-01-13

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/08/2024

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 68-year-old non-hispanic white male had a left tsa on (b)(6) 2009.The patient presented with humeral fracture intra-operatively on (b)(6) 2024.Proximal humeral fracture with removal of stem.The action taken was other ¿ performed orif of prox humerus on (b)(6) 2024 and the outcome of this event is considered resolved on (b)(6) 2024.The case report form indicates that this event is definitely not related to the device and definitely to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(d10) concomitant device(s): 300-10-15 - equinoxe replicator plate 1.5mm o/s : 1309004 300-20-02 - equinox sqre torque define screw drive kit : 1405756 310-02-50 - equinoxe, humeral head tall, 50mm (beta) : 1047097 314-02-14 - equinoxe glenoid, pegged beta, large : 1228723 (h3) pending evaluation.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19212739
• MDR Text Key: 341382545
• Report Number: 1038671-2024-01011
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2013
• Device Catalogue Number: 300-01-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White