MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Catalog Number 320-10-00

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

Patient Problems Fall (1848); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to dislocation after patient fall from traumatic incident.

Manufacturer Narrative

Mdr voided due to patient fall.No allegation of device failure.

Event Description

Index surgery: (b)(6) 2018.Evision due to dislocation after patient fall from traumatic incident.

Event Description

It was reported that a patient was out shopping without her sling (against dr advice) where she was hit by a shopping cart and fell, causing a device dislocation.The patient had been scheduled for an open reduction, when in the surgery it was discovered she completely ruptured the conjoined tendon and the shoulder was too loose after reduction to leave in the same sized implants, the surgeon upsized the implants as needed.The patient was stable upon leaving the o.R.There is no indication or complaint that the devices malfunctioned.No additional information has been provided.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00255, 1038671-2018-00256, 1038671-2018-00258, 1038671-2018-00259 and 1038671-2018-00260.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level, or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the revision for dislocation of the shoulder joint device is related to patient's traumatic event of being hit and falling down.This device is used for treatment, not diagnosis.This event has been reviewed and is found to be reportable.3500a will be filed as required.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7365609
• MDR Text Key: 103304066
• Report Number: 1038671-2018-00257
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR