MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM PRIMARY, PRESS FIT 11MM

Model Number 300-01-11

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

Patient Problem Bone Fracture(s) (1870)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 320-38-00, equinoxe reverse 38mm humeral liner +0.320-10-05, equinoxe reverse tray adapter plate tray +5.320-01-38, equinoxe reverse 38mm glenosphere.320-15-01, eq rev glenoid plate.

Event Description

As reported, approximately 13 months post-op the initial l tsa, during a l tsa revision on this (b)(6) patient, a small shell of bone involving the posterior greater tuberosity and cuff attachment had cracked off and was repaired during procedure.The patient has a history of rtc tear post the initial implant.Patient was hospitalized for 1 day.Devices not returning due to study policy.

Manufacturer Narrative

Section h10: (h3) 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 the implantation of the initial tsa.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11027373
• MDR Text Key: 222174024
• Report Number: 1038671-2020-00652
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 48