MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM E; HIP PROSTHESIS

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 110010244, cup, lot # 6250529, item # 010000857, liner, lot # 6238031.(b)(6).Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-03735, 0001825034-2018-03736.

Event Description

It was reported that multiple liners would not seat properly into the cup.Surgery was finished with backup liner and cup.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection found the hiwall liner to be gouged in multiple locations.Gouges were found on the rim, sidewall, and outer radius of the liner.The barb is lightly roughened but no significant damage was observed on the barb.No dimensional analysis will be performed due to attempts to implant and remove the liner.Review of the device history record identified no deviations or anomalies that would contribute to reported event.Root cause was unable to be determined.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

No further event information available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 36MM E
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7564852
• MDR Text Key: 109901316
• Report Number: 0001825034-2018-03737
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 6183580
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1