BIOMET TIBIAL LOCKING BAR N/A 141205

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 2012-06-06 for BIOMET TIBIAL LOCKING BAR N/A 141205 manufactured by Biomet Orthopedics.

Event Text Entries

[17970612] It was reported that patient with a history of infection underwent knee revision on (b)(6) 2012. A subsequent revision procedure was performed on (b)(6) 2012 due to infection. The joint was washed out and the bearing was removed and washed then reimplanted. The locking bar was removed and replaced. No further information has been provided to date.
Patient Sequence No: 1, Text Type: D, B5


[18176963] The user facility is outside of the united states. No medwatch report was received. Review of device history records show that lot released with no recorded anomaly or deviation. Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. There are warnings in the package insert that state that this type of event can occur: "early or late postoperative infection and allergic reaction. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2012-00803 / 00804).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00804
MDR Report Key2599968
Report Source01,07
Date Received2012-06-06
Date of Report2012-05-10
Date of Event2012-05-06
Date Mfgr Received2012-05-10
Device Manufacturer Date2012-01-22
Date Added to Maude2012-06-06
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 NameBIOMET TIBIAL LOCKING BAR
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-06
Model NumberN/A
Catalog Number141205
Lot Number747020
ID NumberN/A
Device Expiration Date2012-01-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
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 2012-06-06

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