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

Model Number N/A

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 09/18/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee replacement surgery on (b)(6), 2003.Revision procedure was performed on (b)(6), 2014 due to bearing 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.Item is to be returned.Upon return of item and completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

The oxford meniscal bearing was revised after 11 years and 5 months due to ¿bearing wear¿.It is reported that the patient fell and the bearing dislodged medially, however the date of the fall has not been reported hence it is unknown how long the bearing was functioning in this location.The severe deformation on the medial side of the inferior articulating surface suggests that the meniscal bearing was overhanging the tibial tray prior to revision.The lateral side of the superior articulating surface exhibits severe delamination and discoloration which may be indicative of femoral impingement.Both the inferior and superior articulating surfaces exhibit a large number of indentations which suggests that third body wear also may have occurred.The potential femoral edge wear and possible source of third body particles cannot be confirmed without radiographic images.An assessment of the positioning, sizing and alignment of the bearing is also unable to be made.Therefore, the ultimate cause for the adverse bearing wear cannot be determined.

• Brand Name: OXFORD PKS MEN BEARING UHMWPE LARGE 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): .; 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: 4173548
• MDR Text Key: 16303002
• Report Number: 3002806535-2014-00233
• 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,User Facility,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: 10/30/2007
• Device Model Number: N/A
• Device Catalogue Number: 154635
• Device Lot Number: 566506
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2002
• 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