MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, KEELED, CEMENTED, BETA

Catalog Number 314-01-13

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 11/28/2008

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2008.Revision due to glenoid loosening confirmed by ct-scan (b)(6) 2008.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) loosening, which damaged the bond of the implant to the bone.

Event Description

Index surgery: (b)(6) 2005.Revision due to aseptic glenoid loosening.The case report form indicates this event is unlikely related to devices and procedure.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE GLENOID, KEELED, CEMENTED, BETA
• Type of Device: GLENOID
• 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: 7703189
• MDR Text Key: 114458118
• Report Number: 1038671-2018-00617
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-01-13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• 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: 53 YR