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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD CR POR FEMORAL-LT 60 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VANGUARD CR POR FEMORAL-LT 60 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Code Available (3191)
Event Date 01/28/2015
Event Type  Injury  
Event Description

It was reported that patient underwent left total knee arthroplasty on (b)(6) 2014. Subsequently, patient was revised on (b)(6) 2015 due to suspected lack of bone growth on the porous femoral component, an effusion and stiffness. The femoral stem, locking bar and tibial bearing 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 related to the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, excessive weight, and/or excessive unusual and/or awkward movement and/or activity. ".

 
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Brand NameVANGUARD CR POR FEMORAL-LT 60
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 Key4534380
MDR Text Key5359148
Report Number0001825034-2015-00646
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK033489
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number183064
Device LOT Number233880
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/20/2013
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: 02/23/2015 Patient Sequence Number: 1
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