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Adverse Event Report

DEPUY ORTHOPAEDICS, INC. GLOBAL ADVANTAGE PC STEM 8MM TOTAL SHOULDER PROSTHESIS   back to search results
Catalog Number 113708050
Device Problems Dislodged; Implant, removal of
Event Date 04/26/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Disassociation of humeral head. Pt rolled over in bed.

 
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 NameGLOBAL ADVANTAGE PC STEM 8MM
Type of DeviceTOTAL SHOULDER PROSTHESIS
Baseline Brand NameGLOBAL ADVANTAGE PC STEM 8MM
Baseline Generic NameSHOULDER STEM
Baseline Catalogue Number113708050
Baseline Device FamilyGLOBAL ADVANTAGE SHOULDER STEM
Baseline Device 510(K) NumberK011047
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed06/28/2001
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 Contact
hans kusserow, mgr
700 orthopaedic drive
warsaw , IN 46581-0988
(574) 372 -7416
Device Event Key453071
MDR Report Key464130
Event Key439809
Report Number1818910-2003-00344
Device Sequence Number1
Product CodeMBF
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 05/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number113708050
Device LOT NumberW4VCD1006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/07/2003
Event Location Hospital
Date Manufacturer Received05/07/2003
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2002
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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