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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 2
OPTIMOTION IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNAL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1163 1163

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2191 2191
Adverse Event Without Identified Device or Use Problem 804 804
Unstable 756 756
Break 636 636
Fracture 495 495
Loss of Osseointegration 283 283
Naturally Worn 182 182
Osseointegration Problem 165 165
Migration or Expulsion of Device 142 142
Malposition of Device 129 129
Loose or Intermittent Connection 126 126
Noise, Audible 126 126
Device Contamination with Chemical or Other Material 123 123
Device Operates Differently Than Expected 116 116
Detachment of Device or Device Component 115 115
Appropriate Term/Code Not Available 109 109
Difficult to Insert 105 105
Material Integrity Problem 104 104
Packaging Problem 97 97
Mechanical Problem 97 97
Material Deformation 96 96
Device Dislodged or Dislocated 90 90
Component Missing 86 86
Degraded 83 83
Loosening of Implant Not Related to Bone-Ingrowth 82 82
Crack 76 76
Migration 65 65
Connection Problem 59 59
Manufacturing, Packaging or Shipping Problem 48 48
Scratched Material 47 47
Positioning Problem 45 45
Inadequacy of Device Shape and/or Size 39 39
Fitting Problem 38 38
Device Slipped 36 36
Failure To Adhere Or Bond 35 35
Material Discolored 34 34
Material Erosion 32 32
Mechanical Jam 32 32
Corroded 31 31
Dull, Blunt 30 30
Device Packaging Compromised 29 29
Positioning Failure 27 27
Unintended Movement 25 25
Loss of or Failure to Bond 24 24
Detachment Of Device Component 22 22
Contamination /Decontamination Problem 18 18
Material Separation 18 18
Use of Device Problem 17 17
Material Fragmentation 17 17
Failure to Osseointegrate 17 17
Incomplete or Inadequate Connection 17 17
Material Distortion 16 16
Device Damaged Prior to Use 16 16
Tear, Rip or Hole in Device Packaging 15 15
Device Contaminated During Manufacture or Shipping 14 14
Metal Shedding Debris 14 14
Patient Device Interaction Problem 14 14
Improper or Incorrect Procedure or Method 13 13
Peeled/Delaminated 13 13
Residue After Decontamination 12 12
Device-Device Incompatibility 12 12
Difficult To Position 12 12
Device Difficult to Setup or Prepare 12 12
Defective Device 11 11
Failure to Align 10 10
Device Reprocessing Problem 10 10
Delivered as Unsterile Product 10 10
Device Inoperable 10 10
Off-Label Use 9 9
Nonstandard Device 8 8
Patient-Device Incompatibility 8 8
No Apparent Adverse Event 8 8
Sticking 8 8
Defective Component 7 7
Device Markings/Labelling Problem 7 7
Difficult to Open or Remove Packaging Material 7 7
Difficult to Remove 7 7
Device Damaged by Another Device 6 6
Material Twisted/Bent 6 6
Device Handling Problem 6 6
Contamination 6 6
Flaked 6 6
Mechanics Altered 5 5
Physical Resistance/Sticking 5 5
Pitted 5 5
Shipping Damage or Problem 5 5
Component Incompatible 5 5
Delamination 4 4
Dent in Material 4 4
Entrapment of Device 4 4
Device Disinfection Or Sterilization Issue 3 3
Compatibility Problem 3 3
Activation, Positioning or SeparationProblem 3 3
Deformation Due to Compressive Stress 3 3
Expiration Date Error 3 3
Torn Material 3 3
Collapse 3 3
Disassembly 3 3
Device Expiration Issue 3 3
Bent 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2238 2238
Pain 1652 1652
Unspecified Infection 622 622
No Clinical Signs, Symptoms or Conditions 606 606
No Consequences Or Impact To Patient 604 604
No Known Impact Or Consequence To Patient 580 580
No Information 486 486
Inadequate Osseointegration 444 444
Ambulation Difficulties 383 383
No Code Available 326 326
Loss of Range of Motion 311 311
Swelling 252 252
No Patient Involvement 246 246
Bone Fracture(s) 167 167
Fall 152 152
Limited Mobility Of The Implanted Joint 149 149
Joint Laxity 135 135
Scar Tissue 109 109
Insufficient Information 99 99
Failure of Implant 81 81
Inflammation 81 81
Reaction 80 80
Joint Dislocation 63 63
Osteolysis 57 57
Adhesion(s) 49 49
Hematoma 41 41
Muscular Rigidity 40 40
Swelling/ Edema 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Tissue Damage 33 33
Discomfort 32 32
Joint Swelling 29 29
Aspiration/Inhalation 29 29
Wound Dehiscence 27 27
Synovitis 27 27
Embolism 25 25
Damage to Ligament(s) 25 25
Fibrosis 24 24
Arthritis 24 24
Bacterial Infection 21 21
Numbness 20 20
Burning Sensation 17 17
Nerve Damage 16 16
Patient Problem/Medical Problem 15 15
Thrombosis 15 15
Cyst(s) 13 13
Device Embedded In Tissue or Plaque 13 13
Joint Disorder 13 13
Foreign Body In Patient 12 12
Death 12 12
Weakness 11 11
Sepsis 10 10
Hypersensitivity/Allergic reaction 9 9
Pulmonary Embolism 9 9
Impaired Healing 9 9
Bruise/Contusion 8 8
Edema 7 7
Cellulitis 7 7
Erythema 7 7
Muscle Weakness 7 7
Rupture 7 7
Muscle/Tendon Damage 6 6
Osteopenia/ Osteoporosis 6 6
Fever 6 6
Skin Discoloration 6 6
Necrosis 6 6
Limb Fracture 6 6
Ossification 5 5
Foreign Body Reaction 5 5
Sleep Dysfunction 5 5
Cramp(s) 4 4
Thrombosis/Thrombus 4 4
Metal Related Pathology 4 4
Scar Excision 4 4
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Anemia 4 4
Rheumatoid Arthritis 4 4
Post Operative Wound Infection 4 4
Subluxation 4 4
Balance Problems 3 3
Arthralgia 3 3
Abdominal Pain 3 3
Laceration(s) 3 3
Calcium Deposits/Calcification 3 3
Rash 3 3
Neuropathy 3 3
Increased Sensitivity 3 3
Chills 3 3
Discharge 2 2
Skin Inflammation 2 2
Fluid Discharge 2 2
Reaction to Medicinal Component of Device 2 2
Neurological Deficit/Dysfunction 2 2
Fatigue 2 2
Abscess 2 2
Hypoxia 2 2
Nausea 2 2
Syncope 2 2
Urticaria 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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