DURALOC OPTION CUP 50MM 159901050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-05 for DURALOC OPTION CUP 50MM 159901050 manufactured by Depuy International Ltd - 8010379.

Event Text Entries

[182173523] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[182173524] Surgeon is reporting a fracture of a ceramic hip inlay left side. Doi: 2006, dor: not planned yet as a continuing care inlay needs to be manufactured first.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06938
MDR Report Key9793254
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2019-08-08
Date of Event2019-01-01
Date Mfgr Received2020-03-27
Device Manufacturer Date2003-10-16
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURALOC OPTION CUP 50MM
Generic NameDURALOC OPTION IMPLANTS : HIP METAL ACETABULAR CUPS
Product CodeMRA
Date Received2020-03-05
Catalog Number159901050
Lot Number1145152
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY INTERNATIONAL LTD - 8010379
Manufacturer AddressST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-05

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