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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 038 05 12 000
Date submitted: 5/14/2012
Manufacturer:DePuy International Limited
Device Type:DePuy DeltaMotion® Acetabular Cup
Description:Hip Implant, Ceramic
Medical Device Identifier:All lots Cat. No: 168-102F 168-104F, 168-106F, 168-108F, 168-110F, 168-112F, 168-114F 168-116F, 168-128F, 168-130F, 168-132F, 168-134F, 168-136F
Reason of Field Safety Corrective Action:During the implantation of a Delta Motion Acetabular Implant, a 0.07mm diameter (approx.) section of wire from the impaction mechanism has become lodged in the rim of the cup or released into the periarticular space, which may have the clinical implications
Remedy Action:Thoroughly clean the entire site prior to closing to ensure the removal of all bone fragments, metallic debris and bone cement." To ensure that the impaction mechanism wire is not caught in the rim of the cup, surgeons should run their finger along the rim of the cup. This is important as overlying tissue may obscure the presence of the wire upon visual inspection.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Middle East, Riyadh, Riyadh, (01) 4603292
Report Source:NCMDR
Source Ref. Number:65EED8131A258
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: DePuy International Limited.pdf