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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOVATION TIBIAL INSERT, SIZE 6, 9MM VE

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MOVATION TIBIAL INSERT, SIZE 6, 9MM VE Back to Search Results
Catalog Number 292-09-706
Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667)
Patient Problem Insufficient Information (4580)
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 lost a large amount of weight and it was causing instability.
 
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Type of DeviceMOVATION TIBIAL INSERT, SIZE 6, 9MM VE
MDR Report Key10806493
MDR Text Key215263018
Report Number1644408-2016-00964
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number292-09-706
Device Lot Number316N1020
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: 11/08/2020 Patient Sequence Number: 1
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