MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Complaint sample was evaluated and the reported event was unable to confirmed.The device was not returned, however a thread like material which appears to be the barb that is used to lock the liner into the ring was returned.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 hip procedure, a liner was driven into a shell and was unable to be secured.Once the liner was taken out, a thread-like material came out allowing the liner to seat within the shell.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 HI-WALL E1 LINER 32MM 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: 9779589
• MDR Text Key: 189004367
• Report Number: 0001825034-2020-00779
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527041
• UDI-Public: 00880304527041
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000928
• Device Lot Number: 6167741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2017
• 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