MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD UNI TIBIAL BEARING MED SZ5; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 04/13/2006

Event Type  Injury  

Event Description

It was reported that patient underwent an initial left partial knee arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2006 due to unknown reasons.All components were removed and replaced with a total knee system.Patient was further revised on (b)(6) 2015 due to instability.The tibial bearing and locking bar were removed and replaced.

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.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02852 / 02853).

• Brand Name: OXFORD UNI TIBIAL BEARING MED SZ5
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; waterton industrial estate; bridgend, great britain CF31 3XA; UK CF31 3XA
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4895104
• MDR Text Key: 19814838
• Report Number: 0001825034-2015-02852
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2015

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: 07/31/2010
• Device Model Number: N/A
• Device Catalogue Number: 154628
• Device Lot Number: 944876
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2005
• 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: 34 YR