MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD XP E1 TIBIAL BEARING RM 9X71; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 05/07/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an initial right total knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to pain from poly sensitivity.Review of radiographs revealed, arthritis with early loss of joint space, sclerosis and mild spurring.The tibial bearing and tibial tray were removed and replaced.

Event Description

It was reported that patient underwent an initial right total knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to synovitis with pain.Review of radiographs revealed arthritis with early loss of joint space, sclerosis and mild spurring.The tibial bearing and tibial tray were removed and replaced.

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions", number 15 states, "postoperative pain".This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02314 / 02315).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

• Brand Name: VANGUARD XP E1 TIBIAL BEARING RM 9X71
• 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: 4805217
• MDR Text Key: 5831004
• Report Number: 0001825034-2015-02314
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132873
• 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
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 195849
• Device Lot Number: 700870
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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: 60 YR