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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Pain (1994); Swelling (2091)

Event Date 05/29/2009

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Review of sterilization certification confirms device was sterilized in accordance with (b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, ¿early or late postoperative, infection, and allergic reaction.¿ number 20 states, "persistent pain." remains implanted.

Event Description

It was reported that the clinical patient underwent a left partial knee procedure on (b)(6) 2009.Subsequently, patient underwent an irrigation and debridement procedure on (b)(6) 2009 due to a superficial wound infection and a non-healing wound.It was reported that patient experienced pain, significant swelling, redness, irritation, and a mild amount of drainage from the distal aspect of the wound.Aspiration found no evidence of infection.During the procedure, several areas of fat necrosis, which was all debrided back to stable viable tissue, and possible infected suture were noted.No further information has been provided.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; brigend 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: 5457710
• MDR Text Key: 38962335
• Report Number: 0001825034-2016-00594
• 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
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 399128
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2007
• 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: 46 YR
• Patient Weight: 102