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

Model Number N/A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign: australia.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental will be submitted.Device location is unknown.

Event Description

It was reported that the initial poly liner was inserted and all was well, the liner was sitting in the cup flush with the shell so the surgeon thought it was good.During the procedure when preparing the stem, the surgeon noticed the poly liner popped back out.Upon inspection, the locking ring was noticed to be damaged and the surgeon asked for a new poly liner.There was a 15 minute delay to get a new poly liner.No additional information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4 g3 g6 h2 h3 h6 h10 visual examination of the provided pictures identified there is damage to the outer radii and the locking mechanism of the liner.It is unknown if the damage occurred prior to implantation or during the assembly attempts.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event 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

There is no update to the prior event description provided.

• Brand Name: G7 NEUTRAL E1 LINER 36MM D
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16285064
• MDR Text Key: 308664212
• Report Number: 0001825034-2023-00198
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526419
• UDI-Public: (01)00880304526419(17)270420(10)7244646
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000856
• Device Lot Number: 7244646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 65 KG