ANKLE TALOR COMP RT N/A PM550899

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 2012-06-06 for ANKLE TALOR COMP RT N/A PM550899 manufactured by Biomet Orthopedics.

Event Text Entries

[2788742] It was reported that patient underwent a patient-matched ankle procedure on (b)(6), 1997. Subsequently, patient underwent revision on (b)(6), 1999, due to collapse of the talus. No further information has been received to date.
Patient Sequence No: 1, Text Type: D, B5


[9826813] 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. There are warnings in the package insert that state that this type of event can occur: under warnings, it states, "improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and a subsequent reduction in the service life of the prosthetic implants". This report is number 2 of 5 mdrs filed for the same event (reference 1825034-2012-00769 / 00773).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001825034-2012-00770
MDR Report Key2600401
Report Source07
Date Received2012-06-06
Date of Report2012-05-07
Date of Event1999-12-07
Date Mfgr Received2012-05-07
Device Manufacturer Date1997-11-17
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 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 NameANKLE TALOR COMP RT
Generic NamePROSTHESIS, KNEE
Product CodeBSN
Date Received2012-06-06
Model NumberN/A
Catalog NumberPM550899
Lot Number339860
ID NumberN/A
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 2012-06-06

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