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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 05/15/2014

Event Type  Injury  

Event Description

It was reported that patient underwent oxford knee surgery on (b)(6) 2012.Revision procedure was performed on (b)(6) 2014 due to pain and metallosis.No further information has been received.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product was returned.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Product to be returned.Upon receipt of product and completion of evaluation, an mdr follow-up report will be sent to the fda.

Manufacturer Narrative

An oxford partial knee replacement was revised after approximately one year and nine months.The returned femoral component and tibial tray show evidence of metal-on-metal contact, which may have contributed to the metallosis found within the joint upon revision.It is not known how this metal-on-metal contact may have occurred, however it is possible that the meniscal bearing may have dislocated at some time during service.The meniscal bearing itself was received in good condition with very few signs of wear and therefore the mechanism of proposed dislocation is not clear.The exact cause for the patient¿s pain and ultimate cause for revision cannot be determined.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT SML 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): BIOMET UK LTD.; 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: 3870667
• MDR Text Key: 15819037
• Report Number: 3002806535-2014-00147
• 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: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 2185341
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• 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