VANGUARD DCM CR TIBIAL BEARING 14MM X 71/75MM N/A 183444

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-13 for VANGUARD DCM CR TIBIAL BEARING 14MM X 71/75MM N/A 183444 manufactured by Biomet Orthopedics.

Event Text Entries

[2668085] It was reported that patient underwent total knee arthroplasty on (b)(6) 2012. Subsequently, patient was revised on (b)(6) 2012, due to infection. The bearing was removed and replaced with another vanguard bearing.
Patient Sequence No: 1, Text Type: D, B5


[9927128] The user facility is outside of the united states. No medwatch report was received. 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 2 states, "early or late postoperative infection and allergic reaction. " review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00843
MDR Report Key2614414
Report Source01,07
Date Received2012-06-13
Date of Report2012-05-21
Date of Event2012-05-15
Date Mfgr Received2012-05-21
Device Manufacturer Date2009-11-30
Date Added to Maude2012-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. ANGELA DICKSON
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743711021
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameVANGUARD DCM CR TIBIAL BEARING 14MM X 71/75MM
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-13
Model NumberN/A
Catalog Number183444
Lot Number737220
ID NumberN/A
Device Expiration Date2014-11-30
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2012-06-13

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