MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD E1 ANT STBLZD BRNG 12 X75; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 02/07/2013

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 6 states, "inadequate range of motion due to improper selection or positioning of components.".

Event Description

It was reported that patient enrolled in a clinical study underwent a right total knee arthroplasty on (b)(6) 2012.Subsequently, patient underwent manipulation and aspiration under anesthesia on (b)(6) 2013 due to arthrofibrosis and limited range of motion.Operative report noted moderate-sized effusion during the procedure.

• Brand Name: VANGUARD E1 ANT STBLZD BRNG 12 X75
• Type of Device: PROSTHESIS, KNEE
• 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: 5305436
• MDR Text Key: 33717197
• Report Number: 0001825034-2015-05028
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: EP-189082
• Device Lot Number: 845670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2012
• 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
• Patient Age: 60 YR
• Patient Weight: 109