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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
ALEXANDRIA RESEARCH TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
KYOCERA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  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
OVERTURE RESURFACING INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 66 66
2015 57 57
2016 107 107
2017 113 113
2018 159 159
2019 177 177
2020 273 273
2021 240 240
2022 259 259
2023 231 231
2024 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 442 442
Fracture 205 205
Insufficient Information 191 191
Break 171 171
Loosening of Implant Not Related to Bone-Ingrowth 102 102
Appropriate Term/Code Not Available 99 99
Loose or Intermittent Connection 45 45
Device Dislodged or Dislocated 39 39
Migration 36 36
Naturally Worn 35 35
Unstable 35 35
Migration or Expulsion of Device 29 29
Crack 28 28
Difficult to Insert 25 25
Malposition of Device 23 23
Mechanical Jam 21 21
Failure To Adhere Or Bond 18 18
Fitting Problem 17 17
Device Slipped 16 16
Loss of Osseointegration 16 16
Connection Problem 16 16
Flaked 16 16
Device Contamination with Chemical or Other Material 15 15
Device Appears to Trigger Rejection 14 14
Material Fragmentation 13 13
Loss of or Failure to Bond 13 13
Noise, Audible 12 12
Material Deformation 11 11
Device Operates Differently Than Expected 10 10
Degraded 9 9
Positioning Failure 9 9
Material Twisted/Bent 9 9
Failure to Osseointegrate 8 8
Corroded 7 7
Packaging Problem 7 7
Material Protrusion/Extrusion 6 6
Nonstandard Device 6 6
Mechanical Problem 6 6
Inadequacy of Device Shape and/or Size 5 5
Defective Device 5 5
No Apparent Adverse Event 5 5
Physical Resistance/Sticking 5 5
Patient Device Interaction Problem 4 4
Incomplete or Inadequate Connection 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Damaged by Another Device 4 4
Component Missing 4 4
Material Erosion 4 4
Detachment Of Device Component 3 3
Peeled/Delaminated 3 3
Difficult To Position 3 3
Tear, Rip or Hole in Device Packaging 3 3
Improper or Incorrect Procedure or Method 3 3
Device Damaged Prior to Use 3 3
Microbial Contamination of Device 3 3
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 3 3
Material Integrity Problem 3 3
Osseointegration Problem 3 3
Positioning Problem 3 3
Scratched Material 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 2 2
Device Packaging Compromised 2 2
Device-Device Incompatibility 2 2
Human-Device Interface Problem 2 2
Incorrect Device Or Component Shipped 2 2
Device Contaminated During Manufacture or Shipping 2 2
Metal Shedding Debris 2 2
Expiration Date Error 2 2
Separation Failure 2 2
Off-Label Use 2 2
Overheating of Device 2 2
Unsealed Device Packaging 2 2
Material Separation 2 2
Difficult to Remove 1 1
Material Rupture 1 1
Device Abrasion From Instrument Or Another Object 1 1
Incorrect Measurement 1 1
Delivered as Unsterile Product 1 1
Misconnection 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Device Expiration Issue 1 1
Material Discolored 1 1
Cut In Material 1 1
Dent in Material 1 1
Device Issue 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Device Operational Issue 1 1
Delamination 1 1
Communication or Transmission Problem 1 1
Unintended Movement 1 1
Output Problem 1 1
Mechanics Altered 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 445 445
No Clinical Signs, Symptoms or Conditions 266 266
Unspecified Infection 149 149
Failure of Implant 131 131
No Known Impact Or Consequence To Patient 126 126
No Information 110 110
Injury 104 104
Bone Fracture(s) 101 101
No Code Available 90 90
Insufficient Information 73 73
Swelling 53 53
Inadequate Osseointegration 46 46
No Consequences Or Impact To Patient 46 46
Loss of Range of Motion 41 41
Joint Dislocation 32 32
Ambulation Difficulties 30 30
Fall 30 30
Limited Mobility Of The Implanted Joint 29 29
Joint Laxity 29 29
Swelling/ Edema 26 26
Foreign Body In Patient 25 25
Device Embedded In Tissue or Plaque 23 23
Arthralgia 23 23
No Patient Involvement 21 21
Osteolysis 20 20
Discomfort 16 16
Patient Problem/Medical Problem 15 15
Implant Pain 15 15
Inflammation 14 14
Arthritis 13 13
Synovitis 12 12
Metal Related Pathology 10 10
Osteopenia/ Osteoporosis 8 8
Joint Disorder 8 8
Numbness 8 8
Cyst(s) 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Necrosis 7 7
Damage to Ligament(s) 6 6
Reaction 5 5
Unspecified Tissue Injury 4 4
Joint Swelling 4 4
Tissue Damage 4 4
Wound Dehiscence 4 4
Abscess 3 3
Hemorrhage/Bleeding 3 3
Scar Tissue 3 3
Deformity/ Disfigurement 3 3
Complaint, Ill-Defined 3 3
Toxicity 3 3
Embolism/Embolus 3 3
Muscular Rigidity 2 2
Laceration(s) 2 2
Hematoma 2 2
Adhesion(s) 2 2
Erosion 2 2
Cellulitis 1 1
Bacterial Infection 1 1
Anemia 1 1
Ossification 1 1
Low Blood Pressure/ Hypotension 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Fatigue 1 1
Infiltration into Tissue 1 1
Nerve Damage 1 1
Sepsis 1 1
Skin Discoloration 1 1
Weakness 1 1
Burning Sensation 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Thromboembolism 1 1
Not Applicable 1 1
Rupture 1 1
Depression 1 1
Post Operative Wound Infection 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Blue Belt Technologies MN II Jun-27-2014
3 Conformis Inc II Jul-15-2009
4 Encore Medical, LP II Nov-20-2020
5 Howmedica Osteonics Corp. II Apr-12-2023
6 Linkbio Corp. II May-04-2023
7 Smith & Nephew Inc II Mar-03-2010
8 Smith & Nephew, Inc. II May-31-2023
9 Smith & Nephew, Inc. II Apr-14-2023
10 Smith & Nephew, Inc. II May-27-2020
11 Stelkast Co II Nov-20-2009
12 Zimmer Biomet, Inc. II Mar-28-2018
13 Zimmer Biomet, Inc. II Mar-14-2018
14 Zimmer Biomet, Inc. II Jan-14-2018
15 Zimmer Biomet, Inc. II Feb-22-2016
16 Zimmer Inc. II Dec-22-2009
17 Zimmer, Inc. II Oct-25-2013
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