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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Description Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Product CodeKRR
Regulation Number 888.3540
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 14
Loose or Intermittent Connection 5
Adverse Event Without Identified Device or Use Problem 5
Material Fragmentation 4
Device Contamination with Chemical or Other Material 4
Migration or Expulsion of Device 3
Break 2
Material Separation 2
Malposition of Device 2
Appropriate Term/Code Not Available 2
Fracture 1
Off-Label Use 1
Difficult to Open or Remove Packaging Material 1
Noise, Audible 1
Metal Shedding Debris 1
Loss of Osseointegration 1
Detachment Of Device Component 1
Failure To Adhere Or Bond 1
Device Operates Differently Than Expected 1
Component Falling 1
Device Dislodged or Dislocated 1
Material Integrity Problem 1
Total Device Problems 55

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-04-2016
2 Zimmer Biomet, Inc. II Mar-14-2018
3 Zimmer Biomet, Inc. II Feb-22-2016

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