• 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 VGXP XP MED TIBIAL BEARING RT 10X71 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 VGXP XP MED TIBIAL BEARING RT 10X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Osteolysis (2377)
Event Date 12/02/2015
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 this type of event can occur: under possible adverse effects, number 1 states, "it has been reported that wear debris may initiate a cellular response resulting in osteolysis, or osteolysis may be a result of loosening of the implant. ".

 
Event Description

It was reported that patient underwent right total knee arthroplasty on (b)(6) 2015. Subsequently, a revision procedure was performed on (b)(6) 2015 due to tibial osteolysis. A review of invoice history reveals the polyethylene tibial bearing and locking bar were removed and replaced during the procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVGXP XP MED TIBIAL BEARING RT 10X71
Type of DevicePROSTHESIS, 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 Key5433877
MDR Text Key38119631
Report Number0001825034-2016-00465
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/17/2019
Device MODEL NumberN/A
Device Catalogue Number195850
Device LOT Number158250
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2014
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 TREATMENT DATA
Date Received: 02/12/2016 Patient Sequence Number: 1
-
-