MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER NEUTRAL E1 32MM SIZE D; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".

Event Description

It was reported that during a total hip arthroplasty procedure the surgeon could not insert the liner into the shell.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Visually examination of the liner identified scratches and material deformed all over the liner surfaces.There is a through screw hole from inside wall to the outside wall of the liner.The screw hole was made to remove the liner from the shell.All the damaged on the liner are likely from attempt to lock the liner into the shell.Review of the mhr included on the complaint did not reveal any indications that any of the parts might have been out of tolerance when they left zimmer biomet control.Base on the investigation results product left zimmer biomet control conforming.Root cause cannot be determined.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected and additional information.This type of event is referenced in the associated risk documentation.Complaint sample was evaluated and the reported event was confirmed.

• Brand Name: G7 ACETABULAR LINER NEUTRAL E1 32MM SIZE D
• Type of Device: PROSTHESIS, HIP
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5950805
• MDR Text Key: 54749087
• Report Number: 0001825034-2016-03632
• 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: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/12/2017

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: Physician
• Device Expiration Date: 02/08/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000848
• Device Lot Number: 3741323
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/19/2017
• Supplement Dates FDA Received: 10/03/2016; 12/01/2016; 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2016
• 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