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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon attempted to insert the neutral liner into the acetabular cup.Although initially it appeared secure, upon a trial reduction the liner dislocated.The liner would not seat after multiple attempts.A high wall liner was used to complete the operation.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).G2: foreign: new zealand.The 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.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d9; g3; h2; h3; h6 visual examination of the returned product identified scratching on the rim of the liner that translates to the same location as scratches on the inner radius.A light scratch was observed near the apex of the outer radius.The barb has been roughened and multiple scallops have been damaged during impaction.They have been deformed such that the surface is bent over the plane made by the rim of the liner.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported issue is attributed to user error, as the returned liner showed deformation on the scallops in the way that it was not aligned properly during impaction.According to surgical technique it states the surgeon should ensure the scallops are aligned correctly in the recessed areas of the shell before inserting.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.

• Brand Name: G7 NEUTRAL E1 LINER 32MM F
• Type of Device: PROSTHESIS, 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: 17271529
• MDR Text Key: 318559681
• Report Number: 0001825034-2023-01494
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000850
• Device Lot Number: 6991358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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