MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM E; PROSTHESIS, HIP

Catalog Number 010000849

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign.The event occurred in (b)(6).This report is being submitted late as it has been identified in remediation.Examination of the returned device does not confirm the report.The device conforms to its specifications as identified in its drawing dimensional review.There are marks on the outer sphere which indicate the liner was misaligned during the impaction process.Review of device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The root cause is attributed to unintended user error in device alignment.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 the liner could not be fully seated into the cup.Another liner was used to complete the surgery without significant delay.No further information has been made available at this time.

• Brand Name: G7 NEUTRAL E1 LINER 32MM E
• 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: 8237112
• MDR Text Key: 132917755
• Report Number: 0001822565-2019-00156
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2019

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: 11/30/2018
• Device Catalogue Number: 010000849
• Device Lot Number: 3187745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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