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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD CR POROUS FEM 75 LT PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VANGUARD CR POROUS FEM 75 LT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 12/07/2015
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 that this type of event can occur: under possible adverse effects, number 6 states, "inadequate range of motion due to improper selection or positioning of components. " number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain. ".

 
Event Description

It was reported a patient underwent an initial left total knee arthroplasty on (b)(6) 2008. Subsequently, the patient was revised on (b)(6) 2015 due to pain around the patient's condyles, slight effusion, and limited range of motion. The surgeon suspected a lack of bony in-growth around the porous femur. The femoral component, bearing, and locking bar were removed and replaced.

 
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Brand NameVANGUARD CR POROUS FEM 75 LT
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 Key5324528
MDR Text Key34279343
Report Number0001825034-2015-05131
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 12/08/2015
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 EXPIRATION Date03/31/2017
Device MODEL NumberN/A
Device Catalogue Number183074
Device LOT Number296230
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 Received12/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2007
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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