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

Catalog Number 320-01-42

Device Problems Contamination (1120); Unstable (1667)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); No Code Available (3191)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision of right shoulder components due to instability and infection.The case report form indicated this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Engineering evaluation noted that the revision was likely the result of infection, which likely contributed to the reported instability, which is addressed in the product labeling under general surgical risks.

Event Description

Index surgery: (b)(6) 2015.Revision of right shoulder components due to instability and infection.The case report form indicated this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE GLENOSPHERE
• Type of Device: EQUINOXE REVERSE 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 ; 3523771140
• MDR Report Key: 7130497
• MDR Text Key: 95264708
• Report Number: 1038671-2017-00887
• 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: 06/26/2018

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: 320-01-42
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 108