MAUDE Adverse Event Report: BIOMET UK LTD OXF ANAT BRG LT MD SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Pain (1994); Swelling (2091)

Event Date 02/28/2011

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.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.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00613 / 00614).Remains implanted.

Event Description

It was reported that the bilateral clinical patient had an initial left partial knee procedure on (b)(6) 2007 and an initial right partial knee procedure on (b)(6) 2007.Subsequently, the patient underwent a right arthroscopic procedure on (b)(6) 2010 due to painful crepitus and synovitis.Operative notes received reported synovectomy, chondroplasty and removal of an osteophyte occurred during the procedure.Patient underwent a left arthroscopic procedure on (b)(6) 2011 due to persistent pain and localized swelling.Operative notes received reported that synovectomy, release of adhesions, and chondroplasty on the left knee occurred during the procedure.

• Brand Name: OXF ANAT BRG LT MD SIZE 4 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: 5457210
• MDR Text Key: 38900660
• Report Number: 0001825034-2016-00613
• 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: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 327894
• Other Device ID Number: N/A
• 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: 05/24/2007
• 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: 63 YR
• Patient Weight: 78