MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM H; PROSTHESIS - HIP

Catalog Number 010000821

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/15/2014

Event Type  malfunction  

Manufacturer Narrative

The product was returned.Completion of the investigation relayed to biomet (b)(4).Product evaluation relayed "returned component was inspected for the outer profile features.The component passed the inspection other than in areas where deformation was present on the liner.This damage likely occurred during the procedure the liner was attempted to be seated.This product likely left biomet control conforming.Product is also currently part of hhed 000103 as well as pa-00441." review of device history records found units released for distribution with no deviation or anomaly.Review of complaint history found no additional issues reported for this lot.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.(b)(4).

Event Description

It was reported that during a total hip arthroplasty on (b)(6) 2014, the liner would not seat in the cup.Another liner was opened and used to complete the procedure without patient injury or delay.

• Brand Name: G7 HI-WALL ARCOMXL LNR 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: 6990337
• MDR Text Key: 90905718
• Report Number: 0001822565-2017-07593
• 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: 04/30/2019
• Device Catalogue Number: 010000821
• Device Lot Number: 3309747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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