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

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); No Information (3190)

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.".

Event Description

It was reported that the patient underwent an initial left oxford knee surgery on (b)(6) 2007.Subsequently, the patient began experiencing pain and discomfort on (b)(6) 2013.It is unknown what caused to pain.Due to unknown health issues, the patient was prohibited from a revision surgery.It is currently unknown if the pain and discomfort has been resolved.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to correct information.Remains implanted.

• Brand Name: OXF ANAT BRG LT MD SIZE 4 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: 5090579
• MDR Text Key: 26264921
• Report Number: 0001825034-2015-04021
• 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: Followup,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159548
• Device Lot Number: 1295860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/08/2015; 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2007
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 100