MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 NEUTRAL ACETABULAR LINER; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During liner insertion, the liner didn't seat in the shell.Damage was noted on the liner's tabs.Another liner was utilized to complete the procedure.

Manufacturer Narrative

This follow up report is being filed to relay additional information.Visual inspection of the liner shows damage to the liner from attempted implantation and removal confirming the complaint.No dimensional analysis was done due to this damage.Dhr were reviewed and no discrepancies were found.Investigation concluded that the reported event was due to misalignment during installation.Review of complaint histories determined no further action is required.Review of complaint history identified no additional complaints for this item for this issue.No additional complaints were identified for this lot.Root cause was undetermined.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 ACETABULAR LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6190200
• MDR Text Key: 62852756
• Report Number: 0001825034-2016-05295
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000836
• Device Lot Number: 3631837
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1