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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 No Code Available (3191)
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 a loose humeral component. The old humeral component was removed (4mmx100) and was replaced with a 6mmx150mm component. Everything else was fine and the patient is doing great. The revision was from the cement coming loose.
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MDR Report Key10687009
MDR Text Key211639464
Report Number1644408-2016-00510
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 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114904
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: 10/15/2020 Patient Sequence Number: 1