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

Catalog Number 320-01-46

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

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032)

Event Date 10/20/2014

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

To pain, decreased range of motion and signs of infection.The case report form indicates this event is not related to devices.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.Engineering evaluation noted that the revision reported was likely the result of a combination of the pain and decreased range of motion, likely caused by the reported fall, and infection, which is addressed in the product labeling under general surgical risks.

Event Description

To pain, decreased range of motion and signs of infection.The case report form indicates this event is not related to devices.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• 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
• MDR Report Key: 6944252
• MDR Text Key: 89267905
• Report Number: 1038671-2017-00750
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 05/29/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 95