MAUDE Adverse Event Report:; INSERT, 3D EX SZ 5RT 9MM

; INSERT, 3D EX SZ 5RT 9MM

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Catalog Number 392-09-705

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

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 an infected.The surgeon took the poly out, washed out the knee and put in a new poly.

1 Device was Involved in the Event
Type of Device	INSERT, 3D EX SZ 5RT 9MM
MDR Report Key	11823473
MDR Text Key	250585691
Report Number	1644408-2017-00991
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	11/27/2020
1 Patient was Involved in the Event
Date FDA Received	05/13/2021
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	No Information
Device Catalogue Number	392-09-705
Device Lot Number	59604484
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Required Intervention;