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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Information (3190)

Event Date 10/11/2013

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2016-01027 / 01029 / 01030).Product location unknown.

Event Description

It was reported that patient underwent left and right partial knee arthroplasty on (b)(6) 2013.Subsequently, patient underwent a left revision on (b)(6) 2013 due to acute intra-articular infection.During the procedure, the tibial bearing was removed and replaced.Furthermore, the patient underwent a second left revision on (b)(6) 2013 due to instability with lateral compartment degeneration.The patient was converted to a total knee system.Patient also underwent a right knee revision on (b)(6) 2013 due to avascular necrosis and lateral femoral condyle collapse.During the procedure the right knee was converted to a total knee system.The patient uses a cane as needed.

Manufacturer Narrative

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

• Brand Name: OXF ANAT BRG LT SM SIZE 5 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterton industrial estate; bridgend CF31 3XA; UK CF31 3XA
• 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: 5523175
• MDR Text Key: 41065713
• Report Number: 0001825034-2016-01030
• 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
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159542
• Device Lot Number: 2807238
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• 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
• Patient Age: 75 YR