OPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR 244-23-11

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 2014-06-04 for OPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR 244-23-11 manufactured by Exactech, Inc..

Event Text Entries

[4571483] Knee revision due to tibial subsidence. This event took place outside of the united states and was discovered during active surveillance for the (b)(4) registry.
Patient Sequence No: 1, Text Type: D, B5


[12087133] The contribution of the devices to the experience reported could not be determined as the devices were not returned for eval. Additionally, the device specific identification info was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1038671-2014-00186
MDR Report Key3877897
Report Source07
Date Received2014-06-04
Date of Report2014-06-04
Date of Event2014-04-13
Date Mfgr Received2014-05-15
Date Added to Maude2014-06-18
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 ContactGRAHAM CUTHBERT
Manufacturer Street2320 N.W. 66TH CT.
Manufacturer CityGAINESVILLE FL 32653
Manufacturer CountryUS
Manufacturer Postal32653
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTETRAK HI-FLEX TIBIAL INSERT, POSTERIOR
Generic NameOPTETRAK HI-FLEX TIBIAL INSERT
Product CodeHSH
Date Received2014-06-04
Catalog Number244-23-11
OperatorHEALTH PROFESSIONAL
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEXACTECH, INC.
Manufacturer Address2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2014-06-04

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