MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE 42MM GLENOSPHERE

Catalog Number 320-01-42

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: 320-15-05 - equinoxe reverse locking screw; 320-20-00 - equinoxe reverse torque defining screw kit; 320-42-10 - equinoxe reverse 42mm humeral const liner +0.

Event Description

Revision due to possible nickel allergy or infection.

Manufacturer Narrative

Expiration date: 15-feb-2023.Occupation: physician.Pma/510(k)number: k063569.This patient called exactech's regulatory department to report that she was going to most likely have a revision due to a nickle allergy or infection.There was no further contact with the patient who did not leave a contact number.This device was used for treatment, not diagnosis.There is no indication that there is a device related problem, at this time there does not appear to be related to the devices.However, that could not be confirmed due to devices were not returned and the patient only communicated limited information.The most likely cause of the reported event is related to the underlying patient condition with allergies or infection.Device manufacture date: 19-feb-2018.Corrections made in the following section(s): (section f) please disregard f6 and f8.These were entered in error.Date received by manufacturer should have been 10-may-2019 on initial submission.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE 42MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8659226
• MDR Text Key: 146680482
• Report Number: 1038671-2019-00312
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/10/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention