MAUDE Adverse Event Report:; MOVATION TIBIAL INSERT, SIZE 6, 18MM VE

; MOVATION TIBIAL INSERT, SIZE 6, 18MM VE

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Catalog Number 292-18-706

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type Injury

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Second revision surgery - due to chronic infection; a second irrigation and drainage was necessary.

1 Device was Involved in the Event
Type of Device	MOVATION TIBIAL INSERT, SIZE 6, 18MM VE
MDR Report Key	10649477
MDR Text Key	210462578
Report Number	1644408-2016-00451
Device Sequence Number	1
Product Code	OIY
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Manufacturer
Type of Report	Initial
Report Date	10/07/2020
1 Patient was Involved in the Event
Date FDA Received	10/08/2020
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	No Information
Device Catalogue Number	292-18-706
Device Lot Number	320N1002
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Hospitalization; Life Threatening; Other; Required Intervention;