MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 40MM F; PROSTHESIS - HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 10/06/2014

Event Type  malfunction  

Manufacturer Narrative

The product was received.Per results relayed by the engineer: a review of the manufacturing history records confirms no abnormalities or deviations reported.Dimensional examination of the returned liners found they were within drawing tolerance specifications.Visual examination found damage on the wall between the tab cut out area, this damage was probably due to the implantation and extraction actions.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for this part/lot.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.Associated package insert 01-50-1233, there are warnings in the package insert that state this kind of event can occur.Under "warnings," it states that "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." 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.Relayed results to sales rep, requesting they be verbally relayed to the customer.

Event Description

It was reported during a bilateral total hip arthroplasty the surgeon had difficulty seating a liner into the cup.Once the liner was in, he noticed there was damage to the liner and he had to remove it.The surgeon had difficulty getting the second liner in place, and attempted 3 or 4 times before finally getting the liner down (the second liner remains implanted).The surgeon is aware of potential causes for obstruction and made sure he checked for that issue during the procedure.The surgeon wants to know if anything in the manufacturing process has changed because he did not seem this difficult to seat until recently.

• Brand Name: G7 HI-WALL E1 LINER 40MM 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: 6928031
• MDR Text Key: 89947391
• Report Number: 0001825034-2017-08132
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• 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: 010000942
• Device Lot Number: 3302991
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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
• Patient Age: 51 YR