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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. EPSILON ACETABULAR SYSTEM DURASUL HOODED INSERT HIP PROSTHESIS

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ZIMMER, INC. EPSILON ACETABULAR SYSTEM DURASUL HOODED INSERT HIP PROSTHESIS Back to Search Results
Catalog Number 437728045
Device Problem Fitting problem
Event Date 12/14/2007
Event Type  Injury  
Event Description

It is reported that during surgery in 2007, the surgeon was not able to insert the device into a converge cup multi-hole firmly. He removed this insert and used another durasul insert flat-type. This patient is infected with hepatitis c.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
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Brand NameEPSILON ACETABULAR SYSTEM DURASUL HOODED INSERT
Type of DeviceHIP PROSTHESIS
Manufacturer (Section F)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section D)
ZIMMER, INC.
p.o. box 708
warsaw IN 46581 0708
Manufacturer (Section G)
Manufacturer Contact
ann recktenwall
p.o. box 708
warsaw , IN 46581-0708
(574) 371 -8028
Device Event Key987564
MDR Report Key1019377
Event Key978088
Report Number1822565-2008-00120
Device Sequence Number1
Product CodeKWB
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/31/2010
Device Catalogue Number437728045
Device LOT Number60390921
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/25/2008
Device Age na
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/24/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2006
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

Patient TREATMENT DATA
Date Received: 03/25/2008 Patient Sequence Number: 1
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