MAUDE Adverse Event Report:; BASEPLATE, ONLAY TIBIA, SIZE37 RM/LL EPIK

; BASEPLATE, ONLAY TIBIA, SIZE37 RM/LL EPIK

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Catalog Number 300-02-037

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583)

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 surgeon removing the smaller insert and putting in a larger poly.The surgeon thought the baseplate had come loose.

1 Device was Involved in the Event
Type of Device	BASEPLATE, ONLAY TIBIA, SIZE37 RM/LL EPIK
MDR Report Key	10687012
MDR Text Key	211639206
Report Number	1644408-2016-00509
Device Sequence Number	1
Product Code	HRY
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Manufacturer
Type of Report	Initial
Report Date	10/09/2020
1 Patient was Involved in the Event
Date FDA Received	10/15/2020
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	No
Device Operator	No Information
Device Catalogue Number	300-02-037
Device Lot Number	A100000
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Required Intervention;