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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall

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Reference Number:	mdprc 024 05 12 000
Date submitted:	5/8/2012

Manufacturer:	Depuy Orthopaedics, Inc
Device Type:	DePuy Cemented, Polished and Cobalt Chromium, FEMORAL STEM
Description:	Cemented, Hip, MoM
Medical Device Identifier:	metal-on-metal (MoM) articulations
Reason of Field Safety Corrective Action:	When used in combination with a metal-on-metal (MoM) articulation of an all metal type, DePuy’s cemented, polished, CoCr femoral hip stems could potentially exhibit corrosion of the polished surfaces which are within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis.
Remedy Action:	DePuy is issuing a Field Safety Notice to advise against the implantation of the following configuration: DePuy’s cemented, polished, CoCr alloy femoral hip stems combined with any approved metal-on-metal (MoM) articulation of an all metal type.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	UK-2012-05-02-086
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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