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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E1 VNGD AS TIB BRG 10X71 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS E1 VNGD AS TIB BRG 10X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Fluid Discharge (2686)
Event Date 12/04/2012
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 1 states, "material sensitivity reactions. ".

 
Event Description

It was reported that patient enrolled in a clinical study underwent a left total knee arthroplasty on (b)(6) 2012. Subsequently, patient underwent an irrigation and debridement on (b)(6) 2012 due to draining hematoma. No further information has been provided.

 
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Brand NameE1 VNGD AS TIB BRG 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 Key5306350
MDR Text Key33754216
Report Number0001825034-2015-05032
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK080528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial
Report Date 12/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2015
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 NumberEP-189060
Device LOT Number268860
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 Received12/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/14/2012
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: 12/17/2015 Patient Sequence Number: 1
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