MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REPLICATOR PLATE 4.5MM O/S

Catalog Number 300-10-45

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

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to possible infection.

Event Description

Index surgery: (b)(6) 2018.Revision due to possible infection.The patient came up for a follow up and complained of shoulder pain.An x-ray was taken and failure of the glenoid was noticed; the glenoid cage had broken off the poly.It should be noted that the patient had another tsa done with gps on (b)(6) 2018.Prior to complaining of shoulder pain the patient was very happy, thus the reason she got her other shoulder.During the date of the revision case the initial plan was to convert to a reverse, however the patient¿s esr was 37 (normal < 30) and crp was 0.4 (normal < 0.3) so it was decided to explant and put in a spacer.All items were removed without too much trouble.Glenoid has a big cavitary defect but should not cause any problems.Patient's health was stable leaving the operating room.

Manufacturer Narrative

Added check for hospitalization - initial or prolonged.Index surgery: (b)(6) 2018.Revision due to possible infection.The patient came up for a follow up and complained of shoulder pain.An x-ray was taken and failure of the glenoid was noticed; the glenoid cage had broken off the poly.It should be noted that the patient had another tsa done with gps on (b)(6) 2018.Prior to complaining of shoulder pain the patient was very happy, thus the reason she got her other shoulder.During the date of the revision case the initial plan was to convert to a reverse, however the patient¿s esr was 37 (normal < 30) and crp was 0.4 (normal < 0.3) so it was decided to explant and put in a spacer.All items were removed without too much trouble.Glenoid has a big cavitary defect but should not cause any problems.Patient's health was stable leaving the operating room.Expiration date: 18-jan-2020, unique identifier (udi) #: (b)(4).Initial reporter occupation: physician.Pma/510(k)number: k042021.The revision reported was likely the result of drilling the hole for the cage glenoid to an insufficient depth, which resulted in the cage bottoming out on the medial scapular wall.The glenoid cavity defect present in the patient likely contributed to the failure of the cage glenoid by providing insufficient support to the cage glenoid.Device manufacture date: 20-jan-2015.Evaluation codes: 1735, 2993.Corrections made in the following section(s): initial reporter name: dr.(b)(6) at (b)(6) hospital.Health professional? yes.Mdr reporting contact name: (b)(6).Report source: health professional.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REPLICATOR PLATE 4.5MM O/S
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8369700
• MDR Text Key: 137121298
• Report Number: 1038671-2019-00090
• Device Sequence Number: 1
• Product Code: KWT
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR