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

Catalog Number 320-01-36

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

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to patient falling and dislocating.

Manufacturer Narrative

It is noted that excessive activity and trauma influence devices and can affect premature device failure.There is no indication that there is a device related problem/malfunction, there is no allegation against any device.The most likely cause of the reported event is related to the trauma and impact when the patient fell.Correction, no evaluation.This device is used for treatment not diagnosis.

Event Description

The outcome was noted to be successful.Associated mfrs: 1038671-2017-00832, 1038671-2017-00833.

• Brand Name: EQUINOXE, REVERSE GLENOSPHERE
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7047978
• MDR Text Key: 93188598
• Report Number: 1038671-2017-00834
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR