MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 300-01-11

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

As reported via clinical study, the 66 year old male patient had a right tsa on (b)(6) 2022.Between (b)(6) 2022 and (b)(6) 2022 the patient developed a greater tuberosity avulsion (humeral fracture - tuberosity), and did not report any injury or trauma.Other action taken: additional physical therapy.The case report form indicates this event is definitely not related to device or procedure.Outcome: resolved.

Manufacturer Narrative

Pending investigation.Humeral liner: 320-38-03.Reverse humeral tray - 320-10-00.Reverse glenosphere - 320-06-38.Reverse glenosphere baseplate - 320-15-01.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17008235
• MDR Text Key: 316293299
• Report Number: 1038671-2023-01149
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/26/2023
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White