MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT XL SIZE 3 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Discharge (2225)

Event Type  Injury  

Event Description

It was reported that a patient enrolled in a clinical study underwent a left partial knee arthroplasty on (b)(6) 2007.Subsequently, patient experienced wound drainage on (b)(6) 2007 and foot swelling on (b)(6) 2007 that was not device related.It was further reported patient was revised on an unknown date due to an unknown reason.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the information provided: date of event - unknown.Expiration date - unknown.Date explanted - unknown.Manufacture date - unknown.

Manufacturer Narrative

This follow-up report is being filed to correct information.Product location unknown.

• Brand Name: OXF ANAT BRG LT XL SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend IN 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: 4329909
• MDR Text Key: 20749284
• Report Number: 0001825034-2014-09117
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2012
• Device Model Number: N/A
• Device Catalogue Number: 159561
• Device Lot Number: 284092
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2007
• 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: 76 YR
• Patient Weight: 107