MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.

Event Description

Index surgery: (b)(6) 2016.Revision due to patient having recurrent dislocations since (b)(6) 2017.The case report indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.The revision reported was likely the result of recurrent dislocations, which is addressed in the product labeling under device specific risks.The surgeon states that the event was "unlikely related" to the devices.

Event Description

Index surgery: (b)(6) 2016.Revision due to patient having recurrent dislocations since (b)(6) 2017.The case report indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 7129480
• MDR Text Key: 95238193
• Report Number: 1038671-2017-00863
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 79