MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 12/31/2015

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.Since biomet utilizes a tyvek lid that contains coating on all of 1 side of the lid and not a zone coated lid, this type of occurrence is common.Most packaging configurations that use a thermoformed tray and top foams, with a fully coated tyvek lid, will have this occur.Since flat top heat platens are used by biomet, when the tray/lid is being heat sealed, it also activates the adhesive in the non seal flange areas and can become adhered to the inner top foam.This occurs for configurations where the inner foam is close to the lid prior to sealing.This accounts for the majority of packaging configurations, since the goal is to limit movement as much as possible and eliminate dead space between the part and the sterile barrier.Biomet looks at this as an added packaging design feature as the top foam is automatically removed with the lid when the product is opened.As long as the lid is removed properly, there should not be an issue.There are no signs of the product or bag the product was in actually being adhered to the foam or lid.The product in the pouch was able move freely in the tray between the foams.It is just the top foam that was adhered to the lid, not the product or inner pouch.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause of the reported event was determined to be the packaging of the component.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.

Event Description

It was reported that during an initial total hip arthroplasty, when the liner was opened, the inner foam padding was stuck to the tyvek lid, causing the liner to be ejected from the package and onto the floor.In addition, the circulating nurse was unable to safely removed the liner from the vacuum sealed pouch due to the implant's proximity to the cut/tear line.There was a short delay while the sales rep got another liner and the procedure was completed without issue.No adverse events have been reported as a result of the malfunction.

• Brand Name: G7 NEUTRAL E1 LINER 36MM H
• Type of Device: PROSTHESIS, HIP
• 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: 6965210
• MDR Text Key: 90675458
• Report Number: 0001825034-2017-09314
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000860
• Device Lot Number: 3378340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• 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