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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 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1034 1034
2017 1006 1006
2018 1189 1189
2019 1390 1390
2020 1087 1087
2021 445 445

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2151 2151
Unstable 684 684
Adverse Event Without Identified Device or Use Problem 677 677
Break 513 513
Fracture 419 419
Loss of Osseointegration 250 250
Osseointegration Problem 156 156
Naturally Worn 155 155
Migration or Expulsion of Device 142 142
Malposition of Device 123 123
Device Contamination with Chemical or Other Material 123 123
Noise, Audible 119 119
Device Operates Differently Than Expected 116 116
Appropriate Term/Code Not Available 105 105
Material Integrity Problem 104 104
Loose or Intermittent Connection 101 101
Packaging Problem 97 97
Detachment of Device or Device Component 97 97
Mechanical Problem 93 93
Difficult to Insert 84 84
Device Dislodged or Dislocated 82 82
Component Missing 77 77
Degraded 75 75
Material Deformation 73 73
Loosening of Implant Not Related to Bone-Ingrowth 68 68
Crack 58 58
Migration 57 57
Manufacturing, Packaging or Shipping Problem 47 47
Positioning Problem 45 45
Scratched Material 45 45
Inadequacy of Device Shape and/or Size 38 38
Failure To Adhere Or Bond 35 35
Material Discolored 34 34
Device Slipped 34 34
Fitting Problem 33 33
Connection Problem 33 33
Dull, Blunt 30 30
Device Packaging Compromised 29 29
Material Erosion 28 28
Corroded 28 28
Mechanical Jam 26 26
Positioning Failure 23 23
Unintended Movement 23 23
Detachment Of Device Component 22 22
Loss of or Failure to Bond 21 21
Contamination /Decontamination Problem 18 18
Material Distortion 16 16
Device Damaged Prior to Use 16 16
Material Separation 16 16
Failure to Osseointegrate 16 16
Use of Device Problem 14 14
Metal Shedding Debris 14 14
Patient Device Interaction Problem 14 14
Tear, Rip or Hole in Device Packaging 14 14
Improper or Incorrect Procedure or Method 13 13
Peeled/Delaminated 13 13
Residue After Decontamination 12 12
Difficult To Position 12 12
Device Contaminated During Manufacture or Shipping 11 11
Device-Device Incompatibility 10 10
Delivered as Unsterile Product 10 10
Device Inoperable 10 10
Device Difficult to Setup or Prepare 10 10
Off-Label Use 9 9
Failure to Align 9 9
Patient-Device Incompatibility 8 8
No Apparent Adverse Event 8 8
Nonstandard Device 8 8
Sticking 8 8
Defective Component 7 7
Material Fragmentation 7 7
Difficult to Open or Remove Packaging Material 7 7
Defective Device 7 7
Device Damaged by Another Device 6 6
Device Handling Problem 6 6
Difficult to Remove 6 6
Contamination 6 6
Flaked 5 5
Mechanics Altered 5 5
Pitted 5 5
Shipping Damage or Problem 5 5
Material Twisted/Bent 4 4
Delamination 4 4
Dent in Material 4 4
Entrapment of Device 3 3
Compatibility Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Activation, Positioning or SeparationProblem 3 3
Deformation Due to Compressive Stress 3 3
Torn Material 3 3
Disassembly 3 3
Device Expiration Issue 3 3
Device Reprocessing Problem 3 3
Collapse 3 3
Component Incompatible 3 3
Bent 2 2
Unsealed Device Packaging 2 2
Particulates 2 2
Shelf Life Exceeded 2 2
Therapeutic or Diagnostic Output Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2233 2233
Pain 1548 1548
No Consequences Or Impact To Patient 604 604
No Known Impact Or Consequence To Patient 580 580
Unspecified Infection 580 580
No Information 486 486
Inadequate Osseointegration 401 401
Ambulation Difficulties 332 332
No Code Available 326 326
Loss of Range of Motion 272 272
Swelling 252 252
No Patient Involvement 246 246
No Clinical Signs, Symptoms or Conditions 229 229
Bone Fracture(s) 158 158
Limited Mobility Of The Implanted Joint 149 149
Fall 140 140
Scar Tissue 91 91
Joint Laxity 84 84
Reaction 79 79
Inflammation 75 75
Failure of Implant 59 59
Joint Dislocation 57 57
Osteolysis 54 54
Insufficient Information 51 51
Adhesion(s) 43 43
Hematoma 40 40
Muscular Rigidity 37 37
Tissue Damage 33 33
Discomfort 31 31
Joint Swelling 29 29
Aspiration/Inhalation 29 29
Wound Dehiscence 27 27
Embolism 25 25
Fibrosis 24 24
Damage to Ligament(s) 22 22
Synovitis 22 22
Arthritis 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Numbness 20 20
Bacterial Infection 18 18
Burning Sensation 17 17
Nerve Damage 16 16
Patient Problem/Medical Problem 15 15
Thrombosis 15 15
Swelling/ Edema 14 14
Device Embedded In Tissue or Plaque 13 13
Joint Disorder 13 13
Cyst(s) 13 13
Death 12 12
Foreign Body In Patient 11 11
Weakness 11 11
Impaired Healing 9 9
Pulmonary Embolism 9 9
Sepsis 9 9
Bruise/Contusion 8 8
Edema 7 7
Cellulitis 7 7
Erythema 7 7
Skin Discoloration 6 6
Fever 6 6
Rupture 6 6
Necrosis 6 6
Foreign Body Reaction 6 6
Ossification 5 5
Limb Fracture 5 5
Sleep Dysfunction 5 5
Osteopenia/ Osteoporosis 5 5
Muscle Weakness 5 5
Hypersensitivity/Allergic reaction 4 4
Anemia 4 4
Rheumatoid Arthritis 4 4
Cramp(s) 4 4
Scar Excision 4 4
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Post Operative Wound Infection 4 4
Arthralgia 3 3
Abdominal Pain 3 3
Increased Sensitivity 3 3
Chills 3 3
Calcium Deposits/Calcification 3 3
Neuropathy 3 3
Rash 3 3
Neurological Deficit/Dysfunction 2 2
Fatigue 2 2
Abscess 2 2
Discharge 2 2
Skin Inflammation 2 2
Nausea 2 2
Syncope 2 2
Non-union Bone Fracture 2 2
Urticaria 2 2
Anxiety 2 2
Distress 2 2
Thyroid Problems 2 2
Vomiting 2 2
Subluxation 2 2
Test Result 2 2
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1

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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