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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 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 953 953
2016 1034 1034
2017 1006 1006
2018 1189 1189
2019 1391 1391
2020 682 682

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2379 2379
Unstable 660 660
Adverse Event Without Identified Device or Use Problem 615 615
Break 522 522
Fracture 373 373
Loss of Osseointegration 220 220
Device Operates Differently Than Expected 181 181
Material Integrity Problem 179 179
Naturally Worn 154 154
Migration or Expulsion of Device 152 152
Loose or Intermittent Connection 147 147
Osseointegration Problem 140 140
Device Contamination with Chemical or Other Material 138 138
Appropriate Term/Code Not Available 131 131
Mechanical Problem 130 130
Malposition of Device 125 125
Noise, Audible 123 123
Packaging Problem 113 113
Degraded 91 91
Difficult to Insert 91 91
Manufacturing, Packaging or Shipping Problem 83 83
Detachment of Device or Device Component 81 81
Device Slipped 81 81
Device Dislodged or Dislocated 80 80
Component Missing 67 67
Material Deformation 65 65
Crack 60 60
Positioning Problem 59 59
Migration 56 56
Loosening of Implant Not Related to Bone-Ingrowth 56 56
Failure To Adhere Or Bond 53 53
Scratched Material 48 48
Detachment Of Device Component 43 43
Inadequacy of Device Shape and/or Size 43 43
Device Packaging Compromised 41 41
Fitting Problem 40 40
Material Discolored 39 39
Nonstandard Device 29 29
Unintended Movement 28 28
Use of Device Problem 25 25
Mechanical Jam 23 23
Device Damaged Prior to Use 23 23
Corroded 22 22
Sticking 22 22
Material Erosion 20 20
Pin 20 20
Improper or Incorrect Procedure or Method 20 20
Connection Problem 20 20
Failure to Align 20 20
Tear, Rip or Hole in Device Packaging 19 19
Failure to Osseointegrate 18 18
Mechanics Altered 17 17
Material Distortion 16 16
Material Separation 16 16
Positioning Failure 16 16
Difficult to Remove 15 15
Dull, Blunt 15 15
Peeled/Delaminated 15 15
Metal Shedding Debris 14 14
Difficult To Position 13 13
Loss of or Failure to Bond 13 13
Clamp 13 13
Delivered as Unsterile Product 13 13
Device Inoperable 13 13
Residue After Decontamination 12 12
Material Fragmentation 12 12
Melted 11 11
Material Disintegration 11 11
Difficult to Open or Remove Packaging Material 11 11
Contamination 11 11
No Apparent Adverse Event 10 10
Patient-Device Incompatibility 10 10
Device Difficult to Setup or Prepare 9 9
Patient Device Interaction Problem 9 9
Device Contaminated During Manufacture or Shipping 9 9
Contamination /Decontamination Problem 8 8
Pitted 8 8
Off-Label Use 7 7
Defective Device 7 7
Delamination 7 7
Defective Component 7 7
Entrapment of Device 6 6
Device Disinfection Or Sterilization Issue 6 6
Flaked 6 6
Shipping Damage or Problem 6 6
Disassembly 6 6
Screw 6 6
Bearings 6 6
Device Handling Problem 6 6
Device Damaged by Another Device 6 6
Torn Material 5 5
Locking Mechanism 5 5
Collapse 5 5
Device Expiration Issue 5 5
Material Too Rigid or Stiff 5 5
Device-Device Incompatibility 5 5
Compatibility Problem 4 4
Product Quality Problem 4 4
Lock 4 4
Component Falling 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2434 2434
Pain 1567 1567
No Known Impact Or Consequence To Patient 762 762
No Consequences Or Impact To Patient 691 691
Unspecified Infection 619 619
No Information 560 560
No Code Available 526 526
Inadequate Osseointegration 356 356
Ambulation Difficulties 317 317
Swelling 264 264
No Patient Involvement 259 259
Loss of Range of Motion 258 258
Bone Fracture(s) 162 162
Limited Mobility Of The Implanted Joint 155 155
Fall 135 135
Reaction 83 83
Scar Tissue 80 80
Joint Dislocation 61 61
Osteolysis 52 52
Inflammation 52 52
Failure of Implant 51 51
Hematoma 37 37
Adhesion(s) 36 36
Fibrosis 36 36
Joint Swelling 34 34
Muscular Rigidity 31 31
Tissue Damage 28 28
Discomfort 27 27
Synovitis 23 23
Damage to Ligament(s) 23 23
Embolism 23 23
Aspiration/Inhalation 23 23
Wound Dehiscence 23 23
Arthritis 23 23
Numbness 22 22
Device Embedded In Tissue or Plaque 21 21
Foreign Body In Patient 17 17
Burning Sensation 16 16
Patient Problem/Medical Problem 15 15
Thrombosis 15 15
Joint Disorder 13 13
Death 13 13
Nerve Damage 13 13
Weakness 12 12
Impaired Healing 11 11
Cyst(s) 11 11
Pulmonary Embolism 9 9
Sepsis 9 9
Bruise/Contusion 9 9
Bacterial Infection 8 8
Rupture 8 8
Skin Discoloration 7 7
Edema 7 7
Necrosis 7 7
Arthralgia 7 7
Rash 6 6
Erythema 6 6
Sleep Dysfunction 6 6
Osteopenia/ Osteoporosis 5 5
Fever 5 5
Muscle Weakness 5 5
Ossification 5 5
Scarring 4 4
Complaint, Ill-Defined 4 4
Rheumatoid Arthritis 4 4
Anemia 4 4
Fluid Discharge 4 4
Cramp(s) 4 4
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Scar Excision 4 4
Discharge 3 3
Increased Sensitivity 3 3
Chills 3 3
Toxicity 3 3
Hypersensitivity/Allergic reaction 3 3
Fatigue 3 3
Post Operative Wound Infection 3 3
Test Result 3 3
Abdominal Pain 3 3
Syncope 2 2
Cellulitis 2 2
Nausea 2 2
Blood Loss 2 2
Non-union Bone Fracture 2 2
Disability 2 2
Urticaria 2 2
Anxiety 2 2
Thyroid Problems 2 2
Vomiting 2 2
Not Applicable 2 2
Calcium Deposits/Calcification 2 2
Abrasion 2 2
Abscess 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Occlusion 2 2
Staphylococcus Aureus 2 2
Skin Inflammation 2 2
Sweating 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-28-2020
2 Biomet, Inc. II Mar-25-2016
3 DePuy Orthopaedics, Inc. II Jul-20-2015
4 Howmedica Osteonics Corp. II Sep-27-2019
5 Howmedica Osteonics Corp. II Apr-24-2018
6 Howmedica Osteonics Corp. II Apr-20-2018
7 MicroPort Orthopedics Inc. I Sep-08-2016
8 Smith & Nephew, Inc. II Jan-28-2020
9 Smith & Nephew, Inc. II Oct-22-2018
10 Smith & Nephew, Inc. II Jun-11-2018
11 Smith & Nephew, Inc. II May-21-2018
12 Stryker Howmedica Osteonics Corp. II Sep-13-2016
13 Stryker Howmedica Osteonics Corp. II Aug-11-2016
14 Stryker Howmedica Osteonics Corp. II Aug-14-2015
15 Stryker Howmedica Osteonics Corp. II Mar-16-2015
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
22 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
23 Zimmer, Inc. II Mar-12-2015
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