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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
IMPLANTCAST
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 107 107
2017 113 113
2018 159 159
2019 177 177
2020 270 270

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 166 166
Insufficient Information 164 164
Break 90 90
Fracture 70 70
Appropriate Term/Code Not Available 47 47
Loosening of Implant Not Related to Bone-Ingrowth 34 34
Loose or Intermittent Connection 28 28
Migration or Expulsion of Device 23 23
Unstable 22 22
Naturally Worn 17 17
Device Contamination with Chemical or Other Material 14 14
Migration 12 12
Malposition of Device 11 11
Connection Problem 11 11
Difficult to Insert 11 11
Failure To Adhere Or Bond 10 10
Flaked 10 10
Device Dislodged or Dislocated 10 10
Device Slipped 9 9
Material Fragmentation 7 7
Crack 7 7
Loss of or Failure to Bond 7 7
Mechanical Jam 7 7
Nonstandard Device 6 6
Material Protrusion/Extrusion 6 6
Device Operates Differently Than Expected 6 6
Fitting Problem 6 6
Mechanical Problem 5 5
Noise, Audible 5 5
No Apparent Adverse Event 4 4
Packaging Problem 4 4
Degraded 4 4
Positioning Failure 4 4
Difficult To Position 3 3
Microbial Contamination of Device 3 3
Component Missing 3 3
Material Twisted/Bent 3 3
Defective Device 3 3
Positioning Problem 3 3
Detachment Of Device Component 3 3
Inadequacy of Device Shape and/or Size 3 3
Physical Resistance/Sticking 3 3
Lock 2 2
Scratched Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Loss of Osseointegration 2 2
Device-Device Incompatibility 2 2
Tip 2 2
Device Packaging Compromised 2 2
Patient Device Interaction Problem 2 2
Unintended Application Program Shut Down 1 1
Device Component Or Accessory 1 1
Locking Mechanism 1 1
Communication or Transmission Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Device Issue 1 1
Cut In Material 1 1
Device Abrasion From Instrument Or Another Object 1 1
Smoking 1 1
Metal Shedding Debris 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Material Separation 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Incorrect Measurement 1 1
Plate 1 1
Collapse 1 1
Contamination /Decontamination Problem 1 1
Dent in Material 1 1
Device Damaged Prior to Use 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Handpiece 1 1
Pin 1 1
Wire 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Improper or Incorrect Procedure or Method 1 1
Misconnection 1 1
Peeled/Delaminated 1 1
Material Rupture 1 1
Incomplete or Inadequate Connection 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 224 224
No Known Impact Or Consequence To Patient 110 110
Injury 98 98
No Information 91 91
Unspecified Infection 74 74
No Code Available 59 59
Bone Fracture(s) 59 59
Swelling 43 43
No Consequences Or Impact To Patient 39 39
Failure of Implant 27 27
Limited Mobility Of The Implanted Joint 27 27
No Patient Involvement 21 21
Loss of Range of Motion 16 16
Ambulation Difficulties 16 16
No Clinical Signs, Symptoms or Conditions 15 15
Patient Problem/Medical Problem 15 15
Device Embedded In Tissue or Plaque 11 11
Fall 10 10
Osteolysis 8 8
Joint Disorder 8 8
Discomfort 7 7
Inflammation 7 7
Joint Dislocation 6 6
Numbness 5 5
Synovitis 5 5
Reaction 5 5
Joint Swelling 4 4
Foreign Body In Patient 4 4
Necrosis 4 4
Osteopenia/ Osteoporosis 4 4
Cyst(s) 4 4
Wound Dehiscence 3 3
Abscess 3 3
Arthritis 3 3
Metal Related Pathology 3 3
Insufficient Information 2 2
Toxicity 2 2
Fatigue 1 1
Hematoma 1 1
Skin Discoloration 1 1
Nerve Damage 1 1
Damage to Ligament(s) 1 1
Muscular Rigidity 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Tissue Damage 1 1
Weakness 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Not Applicable 1 1
Joint Laxity 1 1
Depression 1 1
Inadequate Pain Relief 1 1
Inadequate Osseointegration 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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