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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Product CodeNPJ
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 35
Break 9
No Known Device Problem 8
Material integrity issue 6
Fracture 5
No code available 5
Positioning Issue 4
Dislodged or dislocated 4
Loss of or failure to bond 4
Malposition of device 3
Difficult to insert 3
Implant, removal of 3
Foreign material present in device 3
Item contaminated during manufacturing or shipping 3
Unstable 3
Material deformation 3
Not Applicable 2
Use of Device Issue 2
Mechanical issue 2
Loss of osseointegration 2
Device packaging compromised 2
Device operates differently than expected 1
Device or device component damaged by another device 1
Loose or intermittent connection 1
Loose 1
Manufacturing or shipping issue associated with device 1
Naturally worn 1
Osseointegration issue 1
Migration of device or device component 1
Difficult to position 1
Size incorrect for patient 1
Slippage of device or device component 1
Improper or incorrect procedure or method 1
Fitting problem 1
Unknown (for use when the device problem is not known) 1
Hole in material 1
Failure to Adhere or Bond 1
Bent 1
Crack 1
Degraded 1
Device expiration issue 1
Total Device Problems 131

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ConforMIS, Inc. II Oct-21-2015
2 Mako Surgical Corporation II Mar-01-2016
3 Mako Surgical Corporation II Mar-04-2014
4 Stryker Howmedica Osteonics Corp. II Jan-11-2012

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