UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-24 for UNKNOWN HIP FEMORAL STEM UNK HIP FEMORAL STEM manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[188225131] (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


[188225132] The primary surgery was performed on an unknown date. It was reported that a revision surgery was performed on an unknown date by replacing c-stem (p/n: unknown). The surgeon found that there was something like a corrosion from the middle to distal part of the explanted stem. 8 out of 11 complaints has been reported that there was corrosion of stem, but it is not determined which complaint has been involved with those complaints (the 11 complaints are: (b)(4)). No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09078
MDR Report Key9873410
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-24
Date of Report2020-03-06
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-24
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 ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
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 NameUNKNOWN HIP FEMORAL STEM
Generic NameHIP FEMORAL STEM
Product CodeKWY
Date Received2020-03-24
Catalog NumberUNK HIP FEMORAL STEM
Lot NumberNA
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 2020-03-24

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