MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HI-WALL E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Malposition of Device (2616); Component or Accessory Incompatibility (2897)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/16/2015

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, it states, ¿improper selection, placement, positioning, alignment and 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 patient underwent an initial hip arthroplasty on (b)(6) 2015.During the procedure, the liner would not seat properly.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition; however, a conclusive root cause could not be determined.

• Brand Name: G7 HI-WALL E1 LINER 36MM F
• 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: 5295343
• MDR Text Key: 34119160
• Report Number: 0001825034-2015-04978
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 3573808
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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): Required Intervention