MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANAT MEN BEARING UHMWPE LT MED SZ 4; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product has been returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

Event Description

It was reported that patient underwent a left unicompartmental knee arthroplasty on (b)(6) 2009.Subsequently, a revision procedure was performed on (b)(6) 2015 due to wear of the polyethylene bearing.During the procedure, the polyethylene bearing was replaced.

• Brand Name: OXFORD PKS ANAT MEN BEARING UHMWPE LT MED SZ 4
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5011837
• MDR Text Key: 23362362
• Report Number: 3002806535-2015-00323
• 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: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 1732103
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2009
• 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