VANGUARD PS OPEN BOX FEMORAL 62.5MM RIGHT-INTERLOK N/A 183106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-14 for VANGUARD PS OPEN BOX FEMORAL 62.5MM RIGHT-INTERLOK N/A 183106 manufactured by Biomet Orthopedics.

Event Text Entries

[2766883] It was reported patient underwent total knee arthroplasty (b)(6) 2009. A subsequent revision was performed (b)(6) 2012 due to pain, tibial lucency and metallosis. The femoral and bearing were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5


[9922739] 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. Listed under possible adverse effects: "material sensitivity reactions. " and "interoperative or postoperative bone fracture and/or postoperative pain. " evaluation in process, but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda. The tibial tray was also removed and reported to biomet (b)(4). This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2012-00836 / 00837).
Patient Sequence No: 1, Text Type: N, H10


[10018566] Review of explanted device found a significant amount of scratches on the condyles of the femoral component. These scratches are consistent with damage caused by third body wear particles in the joint space. Root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00836
MDR Report Key2616856
Report Source07
Date Received2012-06-14
Date of Report2012-05-18
Date of Event2012-04-22
Date Mfgr Received2012-05-18
Device Manufacturer Date2009-01-26
Date Added to Maude2012-06-15
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 EAST BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5742676639
Manufacturer G1BIOMET ORTHOPEDICS
Manufacturer Street56 EAST 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 PS OPEN BOX FEMORAL 62.5MM RIGHT-INTERLOK
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-14
Returned To Mfg2012-05-31
Model NumberN/A
Catalog Number183106
Lot Number057410
ID NumberN/A
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOMET ORTHOPEDICS
Manufacturer Address56 EAST BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2012-06-14

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