CLP HIP 426-00-070

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 2012-02-15 for CLP HIP 426-00-070 manufactured by Encore Medical, L.p..

Event Text Entries

[2522437] Revision surgery - the pt fell and broke their femur. The product did not fail, however, it did need to be replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644408-2012-00072
MDR Report Key2467761
Report Source07
Date Received2012-02-15
Date of Report2012-01-29
Date of Event2012-01-29
Date Mfgr Received2012-01-29
Device Manufacturer Date2011-04-13
Date Added to Maude2012-07-30
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 ContactTEFFANY HUTTO
Manufacturer Street9800 METRIC BLVD.
Manufacturer CityAUSTIN TX 78758
Manufacturer CountryUS
Manufacturer Postal78758
Manufacturer Phone5128346255
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLP HIP
Generic NameSTANDARD OFFSET STEM
Product CodeKWJ
Date Received2012-02-15
Catalog Number426-00-070
Lot Number142C1009
Device Expiration Date2017-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENCORE MEDICAL, L.P.
Manufacturer AddressAUSTIN TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-02-15

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