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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 147
Adverse Event Without Identified Device or Use Problem 98
Break 62
Fracture 62
Migration or Expulsion of Device 25
Loosening of Implant Not Related to Bone-Ingrowth 20
Unstable 17
Appropriate Term/Code Not Available 14
Difficult to Insert 13
Failure To Adhere Or Bond 13
Naturally Worn 12
Loose or Intermittent Connection 11
Flaked 10
Migration 10
Loss of or Failure to Bond 7
Material Fragmentation 7
Malposition of Device 6
Device Dislodged or Dislocated 6
Material Protrusion/Extrusion 6
Mechanical Problem 5
Degraded 4
Device Contamination with Chemical or Other Material 4
Noise, Audible 4
Mechanical Jam 4
No Apparent Adverse Event 4
Packaging Problem 3
Physical Resistance/Sticking 3
Material Twisted/Bent 3
Connection Problem 3
Device Operates Differently Than Expected 3
Positioning Failure 3
Crack 3
Difficult To Position 3
Fitting Problem 3
Component Missing 3
Loss of Osseointegration 2
Inadequacy of Device Shape and/or Size 2
Device Packaging Compromised 2
Device-Device Incompatibility 2
Defective Device 2
Material Integrity Problem 2
Device Contaminated During Manufacture or Shipping 2
Patient Device Interaction Problem 2
Incomplete or Inadequate Connection 1
Scratched Material 1
Unintended Movement 1
Device Component Or Accessory 1
Osseointegration Problem 1
Material Deformation 1
Device Operational Issue 1
Detachment of Device or Device Component 1
Contamination /Decontamination Problem 1
Smoking 1
Device Abrasion From Instrument Or Another Object 1
Off-Label Use 1
Difficult to Remove 1
Material Rupture 1
Material Separation 1
Dent in Material 1
Device Issue 1
Device Damaged Prior to Use 1
Improper or Incorrect Procedure or Method 1
Detachment Of Device Component 1
Incorrect Measurement 1
Misconnection 1
Overheating of Device 1
Peeled/Delaminated 1
Total Device Problems 641

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Smith & Nephew, Inc. II May-27-2020
3 Zimmer Biomet, Inc. II Mar-28-2018
4 Zimmer Biomet, Inc. II Mar-14-2018
5 Zimmer Biomet, Inc. II Jan-14-2018
6 Zimmer Biomet, Inc. II Feb-22-2016

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