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

Model Number N/A

Device Problems Filling Problem (1233); Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 11/17/2014

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation as the product remains implanted.Review of the mhr found the product was released to distribution with no deviations or anomalies.Review of the complaint history determined that no further action is required as no were trends identified.The complaint was not confirmed and the root cause could not be determined.A summary of the investigation has been sent to the complainant.(b)(4).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.Zimmer biomet complaint: (b)(6).

Event Description

During an initial procedure on (b)(6) 2014, surgeon had difficulty seating a liner into a cup.The surgeon was able to finally seat the liner by hitting the side of it.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.

• 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: 6939605
• MDR Text Key: 90247751
• Report Number: 0001825034-2017-08362
• 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: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000741
• Device Lot Number: 3378259
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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