MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD M UNI BRNG B5 LM/RL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 06/04/2012

Event Type  Injury  

Event Description

It was reported patient underwent a right partial knee arthroplasty on (b)(6) 2012.Subsequently, patient was revised on (b)(6) 2012 due to unknown reasons.All components were removed and replaced with a total knee system.A further revision procedure has been indicated due to a loose tibial tray; however, no revision procedure has been reported to date.

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.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015- 01482 / 01483).

• Brand Name: VANGUARD M UNI BRNG B5 LM/RL
• 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: 4686170
• MDR Text Key: 17576172
• Report Number: 0001825034-2015-01482
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2015
• Device Model Number: N/A
• Device Catalogue Number: US154702
• Device Lot Number: 929730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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