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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DISC HUM 4X100MM LT FLANGED C

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DISC HUM 4X100MM LT FLANGED C Back to Search Results
Catalog Number 114904
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
 
Event Description
Revision surgery - according to the surgeon, loosening of humeral component was possibly due to patient poor bone quality because of rheumatoid arthritis.
 
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Type of DeviceDISC HUM 4X100MM LT FLANGED C
MDR Report Key11823321
MDR Text Key250602800
Report Number1644408-2016-00831
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/29/2020
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 Number114904
Device Lot Number941450
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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