MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR EPAK VOLAR RIM PLATE LEFT; TRAUMA IMPLANTS

Model Number N/A

Device Problems Corroded (1131); Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Review of complaint history found no additional related issues for this item, however, there is a known trend on this issue with this brand of product that is being addressed in hhe 15-26 and ca-2242.Review of device history records found these units were released to distribution with no deviations or anomalies.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during a surgery on (b)(6) 2016, the surgeon opened the dvr plate and found that the plate had oxidized.They used another implant to finish to surgery.

• Brand Name: DVR EPAK VOLAR RIM PLATE LEFT
• Type of Device: TRAUMA IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6944447
• MDR Text Key: 89722969
• Report Number: 0001825034-2017-08569
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: PK132704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 811824050
• Device Lot Number: 214097
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1