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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD XP INLK PRI TIB TRAY 75MM; PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VNGD XP INLK PRI TIB TRAY 75MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/03/2015
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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity and/or excessive weight.¿.
 
Event Description
It was reported that patient underwent an initial left total knee arthroplasty on an unknown date.Patient also underwent an initial right total knee arthroplasty on (b)(6) 2014.Subsequently, the patient underwent a right knee revision on (b)(6) 2015 due to tibial loosening and failure of fixation.The tray and bearing were removed and replaced.
 
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Brand Name
VNGD XP INLK PRI TIB TRAY 75MM
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 Key5308210
MDR Text Key33829711
Report Number0001825034-2015-05090
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK122160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Physician
Type of Report Initial
Report Date 12/04/2015
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 Date10/31/2023
Device Model NumberN/A
Device Catalogue Number195251
Device Lot Number764410
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2015
Initial Date FDA Received12/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2013
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 Age58 YR
Patient Weight91
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