MAUDE Adverse Event Report: BIOMET UK LTD OXFORD UNI TIB BRG LG SZ4; PROSTHESIS, KNEE

Model Number N/A

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported patient underwent a left partial knee arthroplasty on (b)(6) 2006 and a right partial knee arthroplasty on (b)(6) 2009.Subsequently, patient underwent a right knee revision procedure on (b)(6) 2013 allegedly due to patient's knee locking up while driving.All components were removed and replaced with a total knee system.Patient alleges the need for a left knee revision procedure due to pain and metal debris.There has been no reported left knee revision procedure 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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, "material sensitivity reactions." number 20 states, "persistent pain." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2013-04750 and 2014-01602).

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Remains implanted.

• Brand Name: OXFORD UNI TIB BRG LG SZ4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend IN CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3676423
• MDR Text Key: 21444585
• Report Number: 0001825034-2014-01602
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 154635
• Device Lot Number: 1154628
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2006
• 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