VANGUARD CR TIBIAL BEARING 12X71/75 N/A 183442

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 2012-06-08 for VANGUARD CR TIBIAL BEARING 12X71/75 N/A 183442 manufactured by Biomet Orthopedics.

Event Text Entries

[2743590] It was reported that patient underwent total knee arthroplasty on (b)(6) 2006. Subsequently, the patient was revised on (b)(6) 2012, due to pain and loosening of the tibial components. The tibial tray, femoral stem, and tibial bearing were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5


[9829434] 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 four states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption or excessive activity". Number fifteen states, "interoperative or postoperative bone fracture and/or postoperative pain". This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2012-00789 / 00791).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00791
MDR Report Key2604139
Report Source01,07
Date Received2012-06-08
Date of Report2012-05-11
Date of Event2012-05-08
Date Mfgr Received2012-05-11
Device Manufacturer Date2006-05-26
Date Added to Maude2012-06-08
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 CR TIBIAL BEARING 12X71/75
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-08
Model NumberN/A
Catalog Number183442
Lot Number444000
ID NumberN/A
Device Expiration Date2011-05-31
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 2012-06-08

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