MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 10 DEG E1 LINER 32MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 04/30/2015

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 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 possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.Discarded.

Event Description

It was reported that patient underwent an initial left total hip arthroplasty on (b)(6) 2015.Subsequently, the patient was revised on (b)(6) 2015 due to infection.An irrigation and debridement was performed.The acetabular liner and femoral head were removed and replaced.

• Brand Name: G7 10 DEG E1 LINER 32MM C
• 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: 5441999
• MDR Text Key: 38371707
• Report Number: 0001825034-2016-00513
• 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: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000886
• Device Lot Number: 3294730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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
• Patient Age: 56 YR
• Patient Weight: 82