MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXD ANATOMIC BRG RT MD SIZE 3; PROSTHESIS, KNEE

Model Number N/A

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported patient underwent a partial right knee arthroplasty on (b)(6) 2007.Subsequently, patient alleges pain and implant locking and clicking.Patient further alleges undergoing radiographs on an unknown date noting dislocation and possible infection or loosening.There has been no reported revision procedure to date.This report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.

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 8 states, "early or late postoperative, infection, and allergic reaction." number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 13 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." number 20 states, 'persistent pain." this report is based on allegations set forth in patient¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2013-05120 and 05122).

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 relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

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

Event Description

It was reported patient underwent a partial right knee arthroplasty on (b)(6), 2007.Subsequently, patient alleges pain.Patient further alleges undergoing x-rays on an unknown date noting implant migration and possible infection or loosening.There has been no reported revision procedure.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: OXD ANATOMIC BRG RT MD SIZE 3
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3947976
• MDR Text Key: 4536815
• Report Number: 0001825034-2013-05122
• 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: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 1384966
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2007
• 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 Weight: 71