MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE COMPRESSION SCREW/LOCKING CAP; SCREW/CAP

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was 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) 2015.Revision of right shoulder components due to aseptic glenoid loosening.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 device was 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 glenoid loosening reported was likely the result of infection, which damaged the bond of the implant to the bone.

Event Description

Index surgery: (b)(6) 2015.Revision of right shoulder components due to aseptic glenoid loosening.This event report was received through clinical data collection activities.

Event Description

Index surgery: (b)(6) 2015.Revision of right shoulder components due to aseptic glenoid loosening.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE COMPRESSION SCREW/LOCKING CAP
• Type of Device: SCREW/CAP
• 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: 6301417
• MDR Text Key: 66771167
• Report Number: 1038671-2017-00078
• 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,Followup
• Report Date: 02/01/2017,07/25/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2017
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: 02/01/2017; 02/01/2017
• Supplement Dates FDA Received: 08/29/2017; 07/25/2018
• 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: 62 YR
• Patient Weight: 74