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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; HEAD, HUMERAL, NEUTRAL, 46-16

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; HEAD, HUMERAL, NEUTRAL, 46-16 Back to Search Results
Catalog Number 520-46-016
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - due to the patient having pain and arthritis on glenoid.The surgeon converted from hemi arthroplasty to a total arthroplasty.
 
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Type of Device
HEAD, HUMERAL, NEUTRAL, 46-16
MDR Report Key10759662
MDR Text Key213857766
Report Number1644408-2016-00690
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number520-46-016
Device Lot Number917C1015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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