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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50

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SHELL, BIPOLAR, MODULAR, ENCORE, SIZE50 Back to Search Results
Catalog Number 412-02-050
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - due to an infection.
 
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Type of DeviceSHELL, BIPOLAR, MODULAR, ENCORE, SIZE50
MDR Report Key11816665
MDR Text Key250349516
Report Number1644408-2017-00501
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number412-02-050
Device Lot Number997B1060
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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