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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Root cause of the liner not fully seating cannot be determined.This is being addressed in (b)(4).Review of complaint history found that (b)(4) have been previously created to address the issue of g7 liners not seating.Review of device history records found one unit was scrapped due to damage.The remaining units were released to distribution with no deviations or anomalies.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 that during a total hip arthroplasty on (b)(6) 2016, the surgeon impacted 32mm c liner in 48mm g7 cup.Liner would not seat flush after 4 attempts.Pulled another 32mm c liner with the same lot number and it seated upon the first attempt.Both were e1.

• Brand Name: G7 NEUTRAL E1 LINER 32MM C
• 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: 6917864
• MDR Text Key: 89473174
• Report Number: 0001825034-2017-08002
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000847
• Device Lot Number: 3563210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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
• Patient Age: 53 YR