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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213817  MPO Knee Instruments; MPO PROPHECY Knee Instrument ...
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTIMOTION IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNAL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1034 1034
2017 1006 1006
2018 1190 1190
2019 1394 1394
2020 1087 1087
2021 1535 1535

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2212 2212
Adverse Event Without Identified Device or Use Problem 962 962
Unstable 813 813
Break 646 646
Fracture 550 550
Loss of Osseointegration 300 300
Naturally Worn 187 187
Osseointegration Problem 170 170
Migration or Expulsion of Device 142 142
Noise, Audible 133 133
Malposition of Device 132 132
Loose or Intermittent Connection 129 129
Detachment of Device or Device Component 126 126
Device Contamination with Chemical or Other Material 123 123
Difficult to Insert 120 120
Device Operates Differently Than Expected 116 116
Appropriate Term/Code Not Available 112 112
Material Integrity Problem 105 105
Packaging Problem 98 98
Mechanical Problem 97 97
Device Dislodged or Dislocated 96 96
Material Deformation 96 96
Loosening of Implant Not Related to Bone-Ingrowth 94 94
Component Missing 86 86
Degraded 85 85
Crack 78 78
Migration 68 68
Connection Problem 59 59
Manufacturing, Packaging or Shipping Problem 48 48
Scratched Material 47 47
Positioning Problem 46 46
Inadequacy of Device Shape and/or Size 40 40
Material Erosion 39 39
Fitting Problem 38 38
Material Discolored 37 37
Device Slipped 36 36
Failure To Adhere Or Bond 35 35
Mechanical Jam 35 35
Corroded 31 31
Dull, Blunt 30 30
Device Packaging Compromised 29 29
Unintended Movement 29 29
Loss of or Failure to Bond 27 27
Positioning Failure 27 27
Detachment Of Device Component 22 22
Use of Device Problem 21 21
Patient Device Interaction Problem 21 21
Contamination /Decontamination Problem 18 18
Material Separation 18 18
Failure to Osseointegrate 17 17
Material Fragmentation 17 17
Incomplete or Inadequate Connection 17 17
Device Damaged Prior to Use 16 16
Material Distortion 16 16
Tear, Rip or Hole in Device Packaging 15 15
Device Contaminated During Manufacture or Shipping 14 14
Metal Shedding Debris 14 14
Improper or Incorrect Procedure or Method 13 13
Device Difficult to Setup or Prepare 13 13
Peeled/Delaminated 13 13
Difficult To Position 12 12
Residue After Decontamination 12 12
Device-Device Incompatibility 12 12
Defective Device 11 11
Off-Label Use 11 11
Delivered as Unsterile Product 10 10
Device Reprocessing Problem 10 10
Device Inoperable 10 10
Failure to Align 10 10
Patient-Device Incompatibility 8 8
No Apparent Adverse Event 8 8
Nonstandard Device 8 8
Sticking 8 8
Defective Component 7 7
Difficult to Remove 7 7
Flaked 7 7
Difficult to Open or Remove Packaging Material 7 7
Device Markings/Labelling Problem 7 7
Device Damaged by Another Device 6 6
Material Twisted/Bent 6 6
Device Handling Problem 6 6
Contamination 6 6
Pitted 6 6
Shipping Damage or Problem 5 5
Component Incompatible 5 5
Mechanics Altered 5 5
Physical Resistance/Sticking 5 5
Delamination 4 4
Dent in Material 4 4
Entrapment of Device 4 4
Disassembly 3 3
Device Expiration Issue 3 3
Collapse 3 3
Expiration Date Error 3 3
Separation Failure 3 3
Deformation Due to Compressive Stress 3 3
Activation, Positioning or SeparationProblem 3 3
Device Disinfection Or Sterilization Issue 3 3
Compatibility Problem 3 3
Torn Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2238 2238
Pain 1750 1750
No Clinical Signs, Symptoms or Conditions 687 687
Unspecified Infection 680 680
No Consequences Or Impact To Patient 604 604
No Known Impact Or Consequence To Patient 580 580
No Information 486 486
Inadequate Osseointegration 458 458
Ambulation Difficulties 426 426
Loss of Range of Motion 342 342
No Code Available 326 326
Swelling 252 252
No Patient Involvement 246 246
Joint Laxity 180 180
Bone Fracture(s) 174 174
Fall 157 157
Limited Mobility Of The Implanted Joint 149 149
Insufficient Information 144 144
Scar Tissue 120 120
Failure of Implant 102 102
Inflammation 89 89
Reaction 80 80
Swelling/ Edema 71 71
Joint Dislocation 66 66
Osteolysis 60 60
Adhesion(s) 56 56
Muscular Rigidity 49 49
Hematoma 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Discomfort 33 33
Tissue Damage 33 33
Joint Swelling 29 29
Wound Dehiscence 29 29
Aspiration/Inhalation 29 29
Damage to Ligament(s) 29 29
Synovitis 29 29
Numbness 27 27
Fibrosis 25 25
Embolism 25 25
Arthritis 24 24
Bacterial Infection 22 22
Burning Sensation 17 17
Nerve Damage 16 16
Thrombosis 15 15
Cyst(s) 15 15
Patient Problem/Medical Problem 15 15
Thrombosis/Thrombus 14 14
Device Embedded In Tissue or Plaque 13 13
Joint Disorder 13 13
Foreign Body In Patient 12 12
Impaired Healing 12 12
Death 12 12
Hypersensitivity/Allergic reaction 12 12
Weakness 11 11
Sepsis 10 10
Necrosis 9 9
Pulmonary Embolism 9 9
Bruise/Contusion 8 8
Cellulitis 7 7
Edema 7 7
Erythema 7 7
Muscle Weakness 7 7
Rupture 7 7
Osteopenia/ Osteoporosis 7 7
Limb Fracture 7 7
Subluxation 7 7
Muscle/Tendon Damage 7 7
Metal Related Pathology 6 6
Skin Discoloration 6 6
Fever 6 6
Foreign Body Reaction 6 6
Ossification 5 5
Neuropathy 5 5
Sleep Dysfunction 5 5
Post Operative Wound Infection 4 4
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Scar Excision 4 4
Cramp(s) 4 4
Anemia 4 4
Rheumatoid Arthritis 4 4
Abdominal Pain 3 3
Fatigue 3 3
Calcium Deposits/Calcification 3 3
Rash 3 3
Laceration(s) 3 3
Deformity/ Disfigurement 3 3
Arthralgia 3 3
Increased Sensitivity 3 3
Chills 3 3
Balance Problems 3 3
Fluid Discharge 2 2
Test Result 2 2
Hyperextension 2 2
Skin Inflammation 2 2
Discharge 2 2
Urticaria 2 2
Anxiety 2 2
Distress 2 2
Vomiting 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Oct-08-2020
2 Biomet, Inc. II May-28-2020
3 Biomet, Inc. II Mar-25-2016
4 Encore Medical, LP II Oct-07-2020
5 Howmedica Osteonics Corp. II Mar-08-2021
6 Howmedica Osteonics Corp. II Sep-27-2019
7 Howmedica Osteonics Corp. II Apr-24-2018
8 Howmedica Osteonics Corp. II Apr-20-2018
9 MicroPort Orthopedics Inc. I Sep-08-2016
10 Smith & Nephew, Inc. II Jan-28-2020
11 Smith & Nephew, Inc. II Oct-22-2018
12 Smith & Nephew, Inc. II Jun-11-2018
13 Smith & Nephew, Inc. II May-21-2018
14 Stryker Howmedica Osteonics Corp. II Sep-13-2016
15 Stryker Howmedica Osteonics Corp. II Aug-11-2016
16 Zimmer Biomet, Inc. II Mar-14-2018
17 Zimmer Biomet, Inc. II Mar-14-2018
18 Zimmer Biomet, Inc. II Apr-25-2017
19 Zimmer Biomet, Inc. II Jun-07-2016
20 Zimmer Biomet, Inc. II Feb-22-2016
21 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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