MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXF UNI TIB TRAY SZA RM/LL PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.

Event Description

It was reported that patient underwent an initial right partial knee procedure on 2011.Patient has experienced pain and difficulty walking.A revision procedure has been indicated due to loosening of the tibial component; however, no revision has been reported at this time.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

Manufacturer Narrative

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

• Brand Name: OXF UNI TIB TRAY SZA RM/LL PMA
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5353144
• MDR Text Key: 35344778
• Report Number: 0001825034-2016-00069
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 154719
• Device Lot Number: 2423537
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2011
• 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: 76