MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT LRG SZ 3; PROSTHESIS, KNEE

Model Number N/A

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 06/27/2014

Event Type  Injury  

Event Description

It was reported that patient underwent oxford knee surgery on (b)(6) 2008.Revision procedure was performed on (b)(6) 2014 due to osteolysis and poly wear.No further information has been received.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT LRG SZ 3
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 3966359
• MDR Text Key: 4636480
• Report Number: 3002806535-2014-00178
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

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: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159582
• Device Lot Number: 1406277
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2007
• 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