SIGMA HP UNI TIB CUT BLK LM/RL 202440100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-24 for SIGMA HP UNI TIB CUT BLK LM/RL 202440100 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2019-111800
MDR Report Key9233810
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-24
Date of Report2019-01-17
Date Mfgr Received2019-10-30
Device Manufacturer Date2009-08-15
Date Added to Maude2019-10-24
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 FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGMA HP UNI TIB CUT BLK LM/RL
Generic NameKNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Product CodeHTZ
Date Received2019-10-24
Catalog Number202440100
Lot NumberA0809
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.