MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD CR ILOK FEM-LT 62.5; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Discolored (1170); Material Integrity Problem (2978)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

It was reported patient underwent a left total knee arthroplasty on (b)(6) 2014.Subsequently, patient alleges experiencing discoloration and pain caused by a possible nickel allergy.There has been no reported revision procedure to date.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

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 1 states, ¿material sensitivity reactions.¿ number 15 states, ¿postoperative pain.¿ this report is number 2 of 2 mdrs filed for the same event (reference (b)(4)).

• Brand Name: VANGUARD CR ILOK FEM-LT 62.5
• 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: 4288473
• MDR Text Key: 19764161
• Report Number: 0001825034-2014-08829
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK023546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2014

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 183026
• Device Lot Number: 324020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• 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): Required Intervention