MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +2.5

Model Number 320-42-03

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): 320-01-42, 6205789 - equinoxe reverse 42mm glenosphere.320-15-05 ,6490616 - eq rev locking screw.

Event Description

As reported, approximately 6 weeks postop the initial implant, the (b)(6) y/o male was revised.This revision was not reported at the time and the reason is unknown.Device was not returned.

Manufacturer Narrative

Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11914097
• MDR Text Key: 259099906
• Report Number: 1038671-2021-00260
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-03
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR