OPTETRAK HI-FLEX TIBIAL INSERT 244-22-13

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 2014-09-15 for OPTETRAK HI-FLEX TIBIAL INSERT 244-22-13 manufactured by Exactech, Inc..

Event Text Entries

[5163055] Revision due to pain and loosening. During revision, it was noted there was no cement mantle on femur or tibial tray.
Patient Sequence No: 1, Text Type: D, B5


[12418850] The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Further, device specific info was not provided, precluding a device history record search.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1038671-2014-00429
MDR Report Key4177441
Report Source07
Date Received2014-09-15
Date of Report2014-09-11
Date of Event2014-08-21
Date Added to Maude2014-10-20
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 Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTETRAK HI-FLEX TIBIAL INSERT
Generic NameHI-FLEX TIBIAL INSERT
Product CodeHSH
Date Received2014-09-15
Catalog Number244-22-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEXACTECH, INC.
Manufacturer Address2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2014-09-15

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