TITANIUM ROOF PILE SCREW 20MM 101101501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-03-20 for TITANIUM ROOF PILE SCREW 20MM 101101501 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[139299009] Product complaint # (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


[139299010] Ppf alleges constrained liner, metallosis and loosening of cup. Doi: (b)(6) 2008 - dor: (b)(6) 2013, (right hip).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2019-87813
MDR Report Key8435670
Report SourceCONSUMER,OTHER
Date Received2019-03-20
Date of Report2014-03-06
Date of Event2014-02-15
Date Mfgr Received2019-04-22
Device Manufacturer Date2005-08-05
Date Added to Maude2019-03-20
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 Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTITANIUM ROOF PILE SCREW 20MM
Generic NameBONE SCREWS AND PINS : SCREWS
Product CodeJDJ
Date Received2019-03-20
Catalog Number101101501
Lot NumberZ2JLG4000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2019-03-20

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