ELITE MODULAR HD 22.225MM +0 9625-67-000 962567000

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 2020-03-23 for ELITE MODULAR HD 22.225MM +0 9625-67-000 962567000 manufactured by Depuy International Ltd - 8010379.

Event Text Entries

[186168595] (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


[186168596] The primary surgery was performed in 2002 (the date was unknown) via tha. It was reported that the revision surgery (the date was unknown) was performed by replacing the c-stem (p/n: unknown) and the cup (p/n: unknown) due to the subluxation which the patient had 3 months before the revision surgery. The revision surgery was completed successfully, and it was unknown whether there was surgical delay or not. The condition after surgery was good. The surgeon found that there was something like a corrosion from the middle point to distal part of the explanted stem. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-08909
MDR Report Key9867986
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-23
Date of Report2020-03-05
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-23
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 DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1LEEDS MFG & MATERIAL WAREHOUSE
Manufacturer StreetST ANTHONYS ROAD
Manufacturer CityLEEDS LS118DT
Manufacturer CountryUK
Manufacturer Postal CodeLS11 8DT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELITE MODULAR HD 22.225MM +0
Generic NameSMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
Product CodeKWY
Date Received2020-03-23
Model Number9625-67-000
Catalog Number962567000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-23

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