MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT MD SIZE 5 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date - unknown.Date implanted - unknown.Date explanted - remains implanted.Manufacture date - unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.Remains implanted.

Event Description

It was reported that the clinical patient underwent left and right partial knee arthroplasty on an unknown date.Subsequently, patient experienced left knee pain in the patella region which is aggravated by bending and climbing stairs.Patient has also experienced swelling.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 20 states, ¿persistent pain.¿.

Manufacturer Narrative

This follow-up report is being filed to correct information and to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the clinical patient underwent left partial knee arthroplasty on (b)(6) 2011 and right partial knee arthroplasty (b)(6) 2012.Subsequently, patient experienced left knee pain and swelling in the patella region which is aggravated by bending and climbing stairs.The pain is relieved with over the counter medication.However, no revision procedure has been reported to date.

• Brand Name: OXF ANAT BRG LT MD SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5517583
• MDR Text Key: 40927174
• Report Number: 0001825034-2016-00983
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: 2193757
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• 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): Required Intervention
• Patient Age: 71 YR