MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HI-WALL E1 LINER 32MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the 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, 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." under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions." device requested, not yet received.

Event Description

Patient underwent a right hip revision approximately 3 days post-implantation due to disassociation of the acetabular liner.The surgeon stated the acetabular cup was not fully seated upon completion of the initial procedure.During the revision procedure, the acetabular liner and femoral head were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay this report is a duplicate of 1825034-2016-01933.

• Brand Name: G7 HI-WALL E1 LINER 32MM 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5813241
• MDR Text Key: 50132518
• Report Number: 0001825034-2016-02707
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000927
• Device Lot Number: 3585146
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention