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

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Sprain (2083); Numbness (2415)

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." remains implanted.

Event Description

It was reported a patient enrolled in a clinical study underwent a right partial knee arthroplasty on (b)(6) 2008.Subsequently, the patient reported numbness in their thigh on (b)(6) 2008.On (b)(6) 2009, the patient reported spraining their knee.On (b)(6) 2009 the patient reported a flare up of low back pain which was treated with injection and pain medication.On (b)(6) 2010 the patient reported experiencing a right ankle injury.On (b)(6) 2015 the patient reported pain in the right knee.On (b)(6) 2016 the patient reported that their knee was buckling and they are experiencing periodic pain.Subsequently, a revision procedure has been indicated; however, no revision procedure has been reported to date.

• Brand Name: OXF ANAT BRG RT MD SIZE 3 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estate; 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: 5585261
• MDR Text Key: 42938663
• Report Number: 0001825034-2016-01326
• 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: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 1444881
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2008
• 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 Weight: 90