MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM F; PROSTHESIS - HIP

Catalog Number 010000741

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/29/2014

Event Type  malfunction  

Manufacturer Narrative

The product was returned.Review of device history records found this unit was released to distribution with no deviations or anomalies.Review of the complaint history found no additional complaints reported for this lot.Completion of the investigation relayed to biomet (b)(4) via etq.Engineer's evaluation relayed "the parts passed inspection of the outer profile with the exception of some deformed areas where the liner is damaged.This damage likely occurred during the procedure.This complaint is currently part of hhed 000103 as well as pa-00441.Product likely left biomet control conforming." 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.Zimmer biomet complaint: (b)(4).

Event Description

It was reported that patient underwent a total hip arthroplasty on an (b)(6) 2014.During the procedure, the surgeon attempted several times to seat the liner in the cup, but was not successful.Another liner was used to complete the procedure without delay or patient injury.

• Brand Name: G7 NEUTRAL ARCOMXL LNR 36MM F
• 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: 6990073
• MDR Text Key: 91198148
• Report Number: 0001822565-2017-07592
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 010000741
• Device Lot Number: 3338473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• 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