MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)

Catalog Number 310-01-44

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2012.Revision due to aseptic glenoid loosening.The case report form indicates this event is possibly related to devices and definitely related to procedure.

Manufacturer Narrative

The revision reported was likely the result of aseptic (non-infected) glenoid loosening, which damaged the bond between the implant and the bone.However, the cause of the glenoid loosening could not be determined because the devices were not available for evaluation and no further details were provided.The following sections have additional updated info: brand name, common device name, catalog number, serial number, expiration date, unique identifier (udi) #, reporting contact first name, reporting contact last name, reporting contact email, date received by manufacturer.

Manufacturer Narrative

Section h11: corrections made in the following section(s): (g4) date received by manufacturer ¿ date on initial submission should have been 11-dec-2018.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8178574
• MDR Text Key: 130786043
• Report Number: 1038671-2018-00957
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2022
• Device Catalogue Number: 310-01-44
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77