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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS CUP

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WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS CUP Back to Search Results
Catalog Number 3802-5460
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/02/2010
Event Type  Malfunction  
Manufacturer Narrative

Investigation is not complete. Trends will be evaluated. This is a reportable malfunction. This report will be updated when the investigation is complete.

 
Event Description

Allegedly, pt has high metal ion levels. Pain in right hip. Lot was part of conserve plus recall.

 
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Brand NameCONSERVE PLUS CUP
Manufacturer (Section F)
WRIGHT MEDICAL TECHNOLOGY, INC.
arlington TN
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
arlington TN
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 airline road
arlington TN 38002
Manufacturer Contact
susan anderson
5677 airline road
arlington , TN 38002
(901) 867 -4140
Device Event Key1666062
MDR Report Key1625932
Event Key1546591
Report Number1043534-2010-00065
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/11/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/04/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3802-5460
Device LOT Number04476844
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2010
Distributor Facility Aware Date02/02/2010
Device Age6 yr
Event Location Hospital
Date Report TO Manufacturer02/16/2010
Date Manufacturer Received02/11/2010
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/01/2004
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: 03/04/2010 Patient Sequence Number: 1
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