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Adverse Event Report

DEPUY INC. DEPUY INC. AGILITY ANKLE TOLAR COMPONENT   back to search results
Catalog Number 1542-45
Patient Outcome  Required Intervention;
Event Description

Pt admitted with a diagnosis of failed right total ankle arthroplasty with fracture of talus unsettling the talar component.

 
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Brand NameDEPUY INC.
Type of DeviceAGILITY ANKLE TOLAR COMPONENT
Baseline Brand NameAGILITY ANKLE TALAR MD
Baseline Generic NameTOTAL ANKLE PROSTHESIS
Baseline Catalogue Number154211500
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
DEPUY INC.
po box 988
*
Device Event Key500101
MDR Report Key511131
Event Key484916
Report NumberMW4003682
Device Sequence Number2
Product CodeHSN
Report Source Voluntary
Report Date 01/07/2004
2 DeviceS WERE Involved in the Event:1 2 
1 Patient Was Involved in the Event
Date FDA Received02/11/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number1542-45
Device LOT Number307240002
OTHER Device ID NumberIMPLANTED 9/27/2002
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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