MODULAR CATHCART BALL 44MM OD 136344000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-22 for MODULAR CATHCART BALL 44MM OD 136344000 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

Report Number1818910-2019-98871
MDR Report Key8811181
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-22
Date of Report2019-06-29
Date of Event2019-06-29
Date Mfgr Received2019-07-25
Device Manufacturer Date2019-01-11
Date Added to Maude2019-07-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 G1JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
Manufacturer StreetNO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK
Manufacturer CitySUZHOU, JIANGSU 215126
Manufacturer CountryCH
Manufacturer Postal Code215126
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMODULAR CATHCART BALL 44MM OD
Generic NameHEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
Product CodeLZY
Date Received2019-07-22
Catalog Number136344000
Lot NumberD18122881
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-22

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