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Adverse Event Report

DEPUY ORTHOPAEDICS, INC. AGILITY ANKLE TALAR MD TOTAL ANKLE PROSTHESIS   back to search results
Catalog Number 154211500
Device Problems Loose; Implant, removal of
Event Date 03/11/2003
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
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Brand NameAGILITY ANKLE TALAR MD
Type of DeviceTOTAL ANKLE PROSTHESIS
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 F)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
hans kusserow, mgr.
700 orthopaedic drive
warsaw , IN 46581-0988
(574) 372 -7416
Device Event Key500101
MDR Report Key511134
Event Key484916
Report Number1818910-2004-00082
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Invalid Data
Remedial Action Other
Type of Report Initial
Report Date 01/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2004
Is This An Adverse Event Report? No
Device Operator Health Professional
Device Catalogue Number154211500
Device LOT Number396421004
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/12/2004
Device Age6 mo
Event Location Hospital
Date Manufacturer Received01/12/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1996
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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