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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 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1089 1089

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2149 2149
Unstable 643 643
Adverse Event Without Identified Device or Use Problem 550 550
Break 433 433
Fracture 367 367
Loss of Osseointegration 243 243
Osseointegration Problem 150 150
Naturally Worn 144 144
Migration or Expulsion of Device 142 142
Device Contamination with Chemical or Other Material 123 123
Malposition of Device 122 122
Device Operates Differently Than Expected 116 116
Noise, Audible 116 116
Appropriate Term/Code Not Available 102 102
Material Integrity Problem 101 101
Packaging Problem 97 97
Mechanical Problem 92 92
Loose or Intermittent Connection 87 87
Detachment of Device or Device Component 82 82
Difficult to Insert 78 78
Degraded 73 73
Device Dislodged or Dislocated 73 73
Component Missing 70 70
Loosening of Implant Not Related to Bone-Ingrowth 62 62
Material Deformation 60 60
Migration 55 55
Crack 53 53
Manufacturing, Packaging or Shipping Problem 47 47
Scratched Material 45 45
Positioning Problem 44 44
Inadequacy of Device Shape and/or Size 37 37
Failure To Adhere Or Bond 35 35
Material Discolored 34 34
Device Slipped 34 34
Fitting Problem 33 33
Device Packaging Compromised 29 29
Material Erosion 23 23
Corroded 23 23
Detachment Of Device Component 22 22
Positioning Failure 22 22
Unintended Movement 21 21
Mechanical Jam 19 19
Connection Problem 19 19
Device Damaged Prior to Use 16 16
Failure to Osseointegrate 16 16
Material Distortion 16 16
Dull, Blunt 15 15
Material Separation 15 15
Tear, Rip or Hole in Device Packaging 14 14
Use of Device Problem 14 14
Metal Shedding Debris 14 14
Improper or Incorrect Procedure or Method 13 13
Peeled/Delaminated 13 13
Loss of or Failure to Bond 13 13
Difficult To Position 12 12
Residue After Decontamination 12 12
Device Contaminated During Manufacture or Shipping 11 11
Device-Device Incompatibility 10 10
Device Difficult to Setup or Prepare 10 10
Device Inoperable 10 10
Delivered as Unsterile Product 9 9
Failure to Align 9 9
Patient Device Interaction Problem 9 9
Contamination /Decontamination Problem 8 8
Patient-Device Incompatibility 8 8
No Apparent Adverse Event 8 8
Sticking 8 8
Nonstandard Device 8 8
Pin 8 8
Off-Label Use 7 7
Material Fragmentation 7 7
Difficult to Open or Remove Packaging Material 7 7
Device Damaged by Another Device 6 6
Defective Device 6 6
Difficult to Remove 6 6
Contamination 6 6
Device Handling Problem 6 6
Pitted 5 5
Shipping Damage or Problem 5 5
Flaked 5 5
Defective Component 5 5
Mechanics Altered 5 5
Delamination 4 4
Activation, Positioning or SeparationProblem 3 3
Device Disinfection Or Sterilization Issue 3 3
Dent in Material 3 3
Compatibility Problem 3 3
Torn Material 3 3
Locking Mechanism 3 3
Device Expiration Issue 3 3
Collapse 3 3
Disassembly 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 2 2
Device Reprocessing Problem 2 2
Component Falling 2 2
Component Incompatible 2 2
Lock 2 2
Bent 2 2
Wire 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 2233 2233
Pain 1491 1491
No Consequences Or Impact To Patient 596 596
No Known Impact Or Consequence To Patient 571 571
Unspecified Infection 536 536
No Information 485 485
Inadequate Osseointegration 390 390
No Code Available 326 326
Ambulation Difficulties 315 315
Swelling 247 247
Loss of Range of Motion 247 247
No Patient Involvement 235 235
Bone Fracture(s) 148 148
Limited Mobility Of The Implanted Joint 146 146
Fall 130 130
Scar Tissue 80 80
Reaction 79 79
Inflammation 69 69
Joint Dislocation 55 55
Osteolysis 53 53
Failure of Implant 49 49
Joint Laxity 42 42
Hematoma 39 39
Insufficient Information 38 38
Adhesion(s) 36 36
Tissue Damage 33 33
Muscular Rigidity 30 30
Joint Swelling 29 29
Discomfort 29 29
Aspiration/Inhalation 29 29
Wound Dehiscence 25 25
Embolism 25 25
Fibrosis 24 24
Damage to Ligament(s) 21 21
Synovitis 21 21
Arthritis 20 20
Numbness 20 20
No Clinical Signs, Symptoms or Conditions 19 19
Burning Sensation 16 16
Patient Problem/Medical Problem 15 15
Nerve Damage 15 15
Thrombosis 15 15
Bacterial Infection 14 14
Device Embedded In Tissue or Plaque 13 13
Joint Disorder 13 13
Death 12 12
Weakness 11 11
Foreign Body In Patient 11 11
Cyst(s) 11 11
Pulmonary Embolism 9 9
Impaired Healing 9 9
Bruise/Contusion 8 8
Sepsis 8 8
Erythema 7 7
Edema 7 7
Necrosis 6 6
Skin Discoloration 6 6
Fever 6 6
Rupture 6 6
Muscle Weakness 5 5
Sleep Dysfunction 5 5
Osteopenia/ Osteoporosis 5 5
Post Operative Wound Infection 5 5
Ossification 5 5
Cellulitis 4 4
Limb Fracture 4 4
Cramp(s) 4 4
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Scar Excision 4 4
Anemia 4 4
Rheumatoid Arthritis 4 4
Rash 3 3
Increased Sensitivity 3 3
Chills 3 3
Arthralgia 3 3
Abdominal Pain 3 3
Swelling/ Edema 3 3
Nausea 2 2
Thyroid Problems 2 2
Syncope 2 2
Non-union Bone Fracture 2 2
Vomiting 2 2
Urticaria 2 2
Anxiety 2 2
Subluxation 2 2
Test Result 2 2
Skin Inflammation 2 2
Discharge 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Calcium Deposits/Calcification 2 2
Abscess 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
High Blood Pressure/ Hypertension 1 1
Infiltration into Tissue 1 1
Aortic Valve Stenosis 1 1
Crushing Injury 1 1
Irritation 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 Sep-27-2019
6 Howmedica Osteonics Corp. II Apr-24-2018
7 Howmedica Osteonics Corp. II Apr-20-2018
8 MicroPort Orthopedics Inc. I Sep-08-2016
9 Smith & Nephew, Inc. II Jan-28-2020
10 Smith & Nephew, Inc. II Oct-22-2018
11 Smith & Nephew, Inc. II Jun-11-2018
12 Smith & Nephew, Inc. II May-21-2018
13 Stryker Howmedica Osteonics Corp. II Sep-13-2016
14 Stryker Howmedica Osteonics Corp. II Aug-11-2016
15 Zimmer Biomet, Inc. II Mar-14-2018
16 Zimmer Biomet, Inc. II Mar-14-2018
17 Zimmer Biomet, Inc. II Apr-25-2017
18 Zimmer Biomet, Inc. II Jun-07-2016
19 Zimmer Biomet, Inc. II Feb-22-2016
20 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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