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

Model Number N/A

Device Problems Sticking (1597); Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.From the investigation, we can conclude that the implant and packaging were conforming to manufacturing specification.Furthermore the complaint was confirmed.The root cause of the reported event was determined to be the packaging of the component; however, no corrections were deemed necessary as validation has been approved for this issue.Review of complaint history found one additional complaint for this item with the same issue (cmp(b)(4)).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

The sales rep reported that during a primary total hip on (b)(6), the operating room nurse opened the liner packaging and the inner foam was stuck to the tyvek lid which caused the implant to fall onto the floor.The sales rep stated that this was user error.Another liner was available and opened to complete the procedure without delay.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Type of Device: PROTHESIS 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: 6945152
• MDR Text Key: 90308739
• Report Number: 0001825034-2017-08585
• 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: distributor,health profession
• 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: 03/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 3530518
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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