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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VNGD XP INLK PRI TIB TRAY 83MM PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VNGD XP INLK PRI TIB TRAY 83MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 06/11/2015
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 (b)(6)2014. Subsequently, patient was revised on (b)(6) 2015 due to aseptic loosening of the tibial component. No further information has been provided.

 
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Brand NameVNGD XP INLK PRI TIB TRAY 83MM
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 Key5322660
MDR Text Key34243846
Report Number0001825034-2015-05120
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK122160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial
Report Date 12/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number195253
Device LOT Number833240
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 Received12/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2013
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 TREATMENT DATA
Date Received: 12/23/2015 Patient Sequence Number: 1
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