• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS OXFORD UNI TIBIAL BEARING MED SZ5; PROSTHESIS, KNEE Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4895104
MDR Text Key19814838
Report Number0001825034-2015-02852
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
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 Date07/31/2010
Device Model NumberN/A
Device Catalogue Number154628
Device Lot Number944876
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2015
Initial Date FDA Received07/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age34 YR
-
-