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

Model Number N/A

Device Problems Difficult To Position (1467); Fitting Problem (2183)

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

Event Date 12/15/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The parts passed inspection of the outer profile as well as the scallop profile.There was some minor damage around the rim of the part.This damage likely occurred during extraction of the liner.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under 4.2.1 and potential harms include poor joint mechanics, significant surgical delay, serious surgical delay, and user dissatisfaction.(b)(4).

Event Description

It was reported that patient underwent a total hip arthroplasty on (b)(6) 2014.During the procedure, the liner would not seat.A new liner was opened and used to complete the procedure.No additional patient consequences were reported.Attempts have been made and no further information has been provided.

• Brand Name: G7 HI-WALL ARCOMXL LNR 36MM G
• Type of Device: HIP PROSTHESIS
• 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: 6909179
• MDR Text Key: 88439411
• Report Number: 0001825034-2017-07715
• 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: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 010000820
• Device Lot Number: 3063136
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2013
• 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