MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HIGH WALL E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Device requested, not yet received.

Event Description

During a right total hip arthroplasty, the poly liner would not seat in the acetabular cup.A ceramic acetabular liner was used to complete the procedure with a 20-minute delay and no patient injury.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that this type of event can occur.Under warnings, number 2 states, "prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component." number 3 states, "tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure.Each component must be fit according to precise operative technique and the use of specified instruments.".

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).

Manufacturer Narrative

This follow-up report is being filed to relay device evaluation, which was unknown at the time of the initial medwatch.Dimensional analysis of the liner were found to be acceptable to print specification.Review of inspection during manufacturing process also shows the product likely left zimmer biomet control conforming.Visually examination of the liner identified scratches on inner radius and material deformation around the scallops, lock flange, and the rim surface, confirming the event.Root cause cannot be determined.Corrective action has been initiated to address reported issue.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.Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information.Concomitant medical product - unknown acetabular cup catalog#: ni lot#: ni.

• Brand Name: G7 HIGH WALL E1 LINER 36MM E
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5763571
• MDR Text Key: 48626839
• Report Number: 0001825034-2016-02413
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK121874
• 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,Followup,Followup,Followup,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 3782622
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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