MAUDE Adverse Event Report: BIOMET UK LTD. OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported that patient underwent primary oxford knee surgery on (b)(6) 2013.Revision procedure was performed on (b)(6) 2014 due to pain and inability to fully straighten the knee.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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

An oxford meniscal bearing has been revised after 13 months due to pain and the patient being unable to straighten their knee fully.The bearing has been received in very good condition with minimal signs of wear which suggests that polyethylene wear was not the ultimate cause for revision.The radiographs provided show that there were a clump of third body particles present to the posterior of the knee which may have been limiting the flexion/extension of the joint.The thickness of the polyethylene bearing may also have been a contributing factor to the limited flexion/extension of the joint however this cannot be confirmed without operative assessment.

• Brand Name: OXF PKS ANAT MEN BRG UHMWPE RT MED SZ 5
• 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: 4186067
• MDR Text Key: 5024232
• Report Number: 3002806535-2014-00240
• 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: 11/24/2014

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: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159577
• Device Lot Number: 2657695
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2012
• 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