MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE LOCKING SCREW

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Revision of shoulder components due to dislocation.The case report form indicates this event is possibly related to devices and definitely related to procedure.

Manufacturer Narrative

This device is used for treatment not diagnosis.The device has not been returned to the manufacturer.

Event Description

The patient's right shoulder is the operative site.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00217, 1038671-2018-00218, 1038671-2018-00219 and 1038671-2018-00220.

• Brand Name: GLENOSPHERE LOCKING SCREW
• Type of Device: LOCKING SCREW
• 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: 7306020
• MDR Text Key: 101260525
• Report Number: 1038671-2018-00220
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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
• Date Manufacturer Received: 12/17/2018
• 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: 70 YR
• Patient Weight: 95