MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE GLENOSPHERE

Catalog Number 320-01-38

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem Unspecified Infection (1930)

Event Date 01/13/2016

Event Type  malfunction  

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.

Event Description

Index surgery: (b)(6) 2010.Revision of left shoulder components due to a loose glenosphere with a broken screw.Infection likely.Surgeon states event is unlikely related to devices.This event report was received through clinical data collection activities.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of glenoid loosening related to a combination of the patient's age, bone quality, and implant placement.

Event Description

Index surgery: (b)(6) 2010.Revision of left shoulder components due to a loose glenosphere with a broken screw.Infection likely.Surgeon states event is unlikely 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 ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5450659
• MDR Text Key: 39139266
• Report Number: 1038671-2016-00168
• 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: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 88 YR
• Patient Weight: 65