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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 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 SA
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 107 107
2017 113 113
2018 159 159
2019 177 177
2020 273 273
2021 172 172

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 228 228
Insufficient Information 165 165
Break 120 120
Fracture 80 80
Appropriate Term/Code Not Available 62 62
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Loose or Intermittent Connection 33 33
Unstable 25 25
Migration or Expulsion of Device 23 23
Naturally Worn 19 19
Crack 16 16
Connection Problem 16 16
Device Contamination with Chemical or Other Material 14 14
Migration 14 14
Difficult to Insert 13 13
Device Dislodged or Dislocated 12 12
Loss of or Failure to Bond 11 11
Flaked 11 11
Malposition of Device 11 11
Failure To Adhere Or Bond 10 10
Device Slipped 9 9
Mechanical Jam 9 9
Material Fragmentation 8 8
Fitting Problem 8 8
Noise, Audible 7 7
Nonstandard Device 6 6
Device Operates Differently Than Expected 6 6
Material Protrusion/Extrusion 6 6
Corroded 6 6
Physical Resistance/Sticking 5 5
Material Twisted/Bent 5 5
Defective Device 5 5
Mechanical Problem 5 5
Packaging Problem 5 5
No Apparent Adverse Event 4 4
Degraded 4 4
Positioning Failure 4 4
Incomplete or Inadequate Connection 4 4
Inadequacy of Device Shape and/or Size 4 4
Positioning Problem 3 3
Detachment Of Device Component 3 3
Difficult To Position 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Expiration Date Error 2 2
Device Packaging Compromised 2 2
Material Separation 2 2
Patient Device Interaction Problem 2 2
Loss of Osseointegration 2 2
Scratched Material 2 2
Contamination /Decontamination Problem 2 2
Device-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Osseointegration Problem 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Material Discolored 1 1
Misconnection 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Unintended Application Program Shut Down 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Device Abrasion From Instrument Or Another Object 1 1
Incorrect Measurement 1 1
Device Operational Issue 1 1
Smoking 1 1
Metal Shedding Debris 1 1
Device Issue 1 1
Cut In Material 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 270 270
No Known Impact Or Consequence To Patient 110 110
Injury 100 100
No Clinical Signs, Symptoms or Conditions 99 99
Unspecified Infection 93 93
No Information 91 91
Bone Fracture(s) 70 70
No Code Available 59 59
Swelling 51 51
Failure of Implant 47 47
No Consequences Or Impact To Patient 40 40
Limited Mobility Of The Implanted Joint 27 27
Ambulation Difficulties 22 22
No Patient Involvement 21 21
Loss of Range of Motion 18 18
Patient Problem/Medical Problem 15 15
Device Embedded In Tissue or Plaque 11 11
Osteolysis 10 10
Fall 10 10
Joint Disorder 8 8
Discomfort 8 8
Inadequate Osseointegration 7 7
Inflammation 7 7
Arthritis 6 6
Joint Dislocation 6 6
Osteopenia/ Osteoporosis 6 6
Swelling/ Edema 6 6
Reaction 5 5
Foreign Body In Patient 5 5
Synovitis 5 5
Metal Related Pathology 5 5
Numbness 5 5
Cyst(s) 5 5
Necrosis 4 4
Joint Swelling 4 4
Arthralgia 3 3
Joint Laxity 3 3
Unspecified Tissue Injury 3 3
Wound Dehiscence 3 3
Abscess 3 3
Insufficient Information 3 3
Hematoma 2 2
Toxicity 2 2
Implant Pain 2 2
Skin Inflammation/ Irritation 1 1
Not Applicable 1 1
Depression 1 1
Inadequate Pain Relief 1 1
Nerve Damage 1 1
Scar Tissue 1 1
Tissue Damage 1 1
Weakness 1 1
Complaint, Ill-Defined 1 1
Hemorrhage/Bleeding 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Ossification 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Skin Discoloration 1 1
Fatigue 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
7 Zimmer Biomet, Inc. II Feb-22-2016
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