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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
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 113 113
2018 159 159
2019 177 177
2020 273 273
2021 241 241

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 219 219
Insufficient Information 144 144
Break 131 131
Fracture 83 83
Appropriate Term/Code Not Available 65 65
Loosening of Implant Not Related to Bone-Ingrowth 45 45
Loose or Intermittent Connection 29 29
Crack 27 27
Unstable 26 26
Migration or Expulsion of Device 22 22
Naturally Worn 17 17
Connection Problem 16 16
Migration 15 15
Difficult to Insert 14 14
Loss of or Failure to Bond 11 11
Flaked 11 11
Malposition of Device 10 10
Mechanical Jam 10 10
Material Fragmentation 9 9
Device Dislodged or Dislocated 8 8
Fitting Problem 8 8
Noise, Audible 7 7
Material Protrusion/Extrusion 6 6
Corroded 6 6
Mechanical Problem 5 5
Device Slipped 5 5
Material Twisted/Bent 5 5
Defective Device 5 5
Packaging Problem 5 5
Physical Resistance/Sticking 5 5
Incomplete or Inadequate Connection 4 4
No Apparent Adverse Event 4 4
Inadequacy of Device Shape and/or Size 4 4
Positioning Failure 4 4
Failure To Adhere Or Bond 4 4
Degraded 4 4
Difficult To Position 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Component Missing 3 3
Device Operates Differently Than Expected 3 3
Device Damaged by Another Device 3 3
Device Packaging Compromised 2 2
Device-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or SeparationProblem 2 2
Loss of Osseointegration 2 2
Microbial Contamination of Device 2 2
Expiration Date Error 2 2
Material Deformation 2 2
Positioning Problem 2 2
Material Separation 2 2
Detachment Of Device Component 2 2
Patient Device Interaction Problem 2 2
Unintended Application Program Shut Down 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Device Reprocessing Problem 1 1
Material Discolored 1 1
Incorrect Measurement 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Misconnection 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Scratched Material 1 1
Unintended Movement 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Cut In Material 1 1
Dent in Material 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged Prior to Use 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 255 255
No Clinical Signs, Symptoms or Conditions 134 134
No Known Impact Or Consequence To Patient 97 97
Injury 96 96
Unspecified Infection 84 84
No Information 75 75
Bone Fracture(s) 70 70
Failure of Implant 54 54
Swelling 50 50
No Consequences Or Impact To Patient 40 40
No Code Available 38 38
Limited Mobility Of The Implanted Joint 26 26
Ambulation Difficulties 21 21
No Patient Involvement 21 21
Loss of Range of Motion 16 16
Foreign Body In Patient 11 11
Device Embedded In Tissue or Plaque 11 11
Insufficient Information 10 10
Osteolysis 10 10
Inadequate Osseointegration 9 9
Joint Disorder 8 8
Discomfort 8 8
Fall 8 8
Inflammation 7 7
Osteopenia/ Osteoporosis 7 7
Swelling/ Edema 7 7
Patient Problem/Medical Problem 6 6
Arthritis 6 6
Cyst(s) 6 6
Synovitis 5 5
Reaction 5 5
Numbness 5 5
Metal Related Pathology 5 5
Joint Swelling 4 4
Joint Dislocation 4 4
Necrosis 4 4
Abscess 3 3
Arthralgia 3 3
Wound Dehiscence 3 3
Embolism/Embolus 3 3
Joint Laxity 3 3
Unspecified Tissue Injury 3 3
Implant Pain 3 3
Hematoma 2 2
Toxicity 2 2
Tissue Damage 1 1
Weakness 1 1
Nerve Damage 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Hemorrhage/Bleeding 1 1
Fatigue 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Ossification 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Bacterial Infection 1 1
Erosion 1 1
Cellulitis 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inadequate Pain Relief 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Encore Medical, LP II Nov-20-2020
3 Smith & Nephew, Inc. II May-27-2020
4 Zimmer Biomet, Inc. II Mar-28-2018
5 Zimmer Biomet, Inc. II Mar-14-2018
6 Zimmer Biomet, Inc. II Jan-14-2018
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