STAND CUP TRIAL D42 +6MM 230742406

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 2019-01-22 for STAND CUP TRIAL D42 +6MM 230742406 manufactured by Depuy France Sas 3003895575.

Event Text Entries

[133842168] (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


[133842169] It was reported that the humeral cup trials have shaving of plastic coming off of them. Had to open three different trays for case. All went well and nothing left in patient.
Patient Sequence No: 1, Text Type: D, B5


[134386877] (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


MAUDE Entry Details

Report Number1818910-2019-81862
MDR Report Key8269059
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-01-22
Date of Report2019-01-03
Date of Event2019-01-03
Date Mfgr Received2019-01-31
Device Manufacturer Date2015-10-27
Date Added to Maude2019-01-22
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 IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE B.P. 256
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTAND CUP TRIAL D42 +6MM
Generic NameEXTREMITY INSTRUMENTS : HUMERAL TRIALS
Product CodeLHX
Date Received2019-01-22
Returned To Mfg2019-01-22
Catalog Number230742406
Lot Number5259017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY FRANCE SAS 3003895575
Manufacturer Address7 ALL?E IR?NE JOLIOT CURIE BP 256 SAINT PRIEST CEDEX 69801 FR 69801


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-22

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