MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM G; PROSTHESIS HIP

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2014

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Engineer¿s evaluation relayed the shell and liner were received assembled.The liner was flush with the shell.There is some damage to the liner on the top face and into the bore, which is assumed was done whilst trying to fit the liner (as per the complaint).On splitting the liner and shell, there was found to be a thin sliver of plastic coming from the retaining ring, and damage to the retaining ring in a similar area to some of the damage on the upper face on the liner.The inside of the shell looked good, and the plugs were all in and sat sub flush to the shell.Some damage was seen on the outside of the shell, but this could have been caused by extraction.It is the conclusion that the liner conformed to drawing, and was not correctly aligned whilst fitting into the shell, and when attempting to engage the liner, it was damaged, thus causing some shearing of the retaining ring and damage.Review of device history records found that these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for these lots.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 patient underwent total hip arthroplasty on (b)(6) 2014 on an unknown side.During the procedure it was noted the liners would not fully seat and the liner was damaged after being unable to seat flush inside cup.

• Brand Name: G7 NEUTRAL E1 LINER 36MM G
• 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: 6908299
• MDR Text Key: 88437349
• Report Number: 0001825034-2017-07721
• 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: 10/02/2017

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000859
• Device Lot Number: 3309851
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1