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TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 4
CONFORMIS INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P. DBA DJO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OPTIMOTION IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SIGNAL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 4
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER TRABECULAR METAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2014 385 385
2015 955 955
2016 1034 1034
2017 1006 1006
2018 1191 1191
2019 1394 1394
2020 1089 1089
2021 1539 1539
2022 1260 1260
2023 1267 1267
2024 531 531

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2782 2782
Adverse Event Without Identified Device or Use Problem 2550 2550
Unstable 1247 1247
Fracture 1111 1111
Break 833 833
Loss of Osseointegration 425 425
Naturally Worn 268 268
Difficult to Insert 247 247
Osseointegration Problem 245 245
Material Integrity Problem 204 204
Loose or Intermittent Connection 203 203
Device Operates Differently Than Expected 197 197
Detachment of Device or Device Component 195 195
Loosening of Implant Not Related to Bone-Ingrowth 190 190
Noise, Audible 183 183
Device Dislodged or Dislocated 181 181
Malposition of Device 177 177
Appropriate Term/Code Not Available 175 175
Degraded 167 167
Mechanical Problem 163 163
Migration or Expulsion of Device 162 162
Device Contamination with Chemical or Other Material 138 138
Migration 137 137
Packaging Problem 127 127
Material Deformation 111 111
Device Slipped 102 102
Crack 92 92
Manufacturing, Packaging or Shipping Problem 92 92
Component Missing 87 87
Unintended Movement 68 68
Positioning Problem 67 67
Use of Device Problem 67 67
Failure To Adhere Or Bond 65 65
Connection Problem 62 62
Material Erosion 62 62
Inadequacy of Device Shape and/or Size 62 62
Fitting Problem 58 58
Positioning Failure 52 52
Scratched Material 52 52
Loss of or Failure to Bond 52 52
Detachment Of Device Component 49 49
Mechanical Jam 47 47
Patient Device Interaction Problem 46 46
Material Discolored 46 46
Device Packaging Compromised 45 45
Corroded 36 36
Device Damaged Prior to Use 35 35
Nonstandard Device 31 31
Tear, Rip or Hole in Device Packaging 31 31
Dull, Blunt 30 30
Improper or Incorrect Procedure or Method 28 28
Failure to Osseointegrate 26 26
Material Fragmentation 25 25
Failure to Align 24 24
Sticking 23 23
Material Separation 22 22
Device Contaminated During Manufacture or Shipping 20 20
Off-Label Use 19 19
No Apparent Adverse Event 18 18
Device Difficult to Setup or Prepare 18 18
Contamination /Decontamination Problem 18 18
Delivered as Unsterile Product 17 17
Difficult to Remove 17 17
Incomplete or Inadequate Connection 17 17
Mechanics Altered 17 17
Material Distortion 16 16
Difficult to Open or Remove Packaging Material 16 16
Peeled/Delaminated 16 16
Defective Device 15 15
Metal Shedding Debris 15 15
Material Disintegration 14 14
Device-Device Incompatibility 14 14
Device Handling Problem 13 13
Difficult To Position 13 13
Device Inoperable 13 13
Device Reprocessing Problem 12 12
Pitted 12 12
Patient-Device Incompatibility 12 12
Residue After Decontamination 12 12
Disassembly 11 11
Melted 11 11
Contamination 11 11
Device Markings/Labelling Problem 10 10
Flaked 9 9
Defective Component 9 9
Entrapment of Device 8 8
Collapse 8 8
Device Disinfection Or Sterilization Issue 7 7
Device Damaged by Another Device 7 7
Shipping Damage or Problem 7 7
Activation, Positioning or Separation Problem 7 7
Delamination 7 7
Compatibility Problem 6 6
Material Twisted/Bent 6 6
Physical Resistance/Sticking 6 6
Dent in Material 6 6
Wrong Label 5 5
Material Too Rigid or Stiff 5 5
Component Incompatible 5 5
Device Expiration Issue 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2885 2885
Injury 2476 2476
No Clinical Signs, Symptoms or Conditions 1282 1282
Unspecified Infection 1208 1208
No Known Impact Or Consequence To Patient 893 893
No Consequences Or Impact To Patient 749 749
Ambulation Difficulties 691 691
Loss of Range of Motion 671 671
No Information 643 643
Inadequate Osseointegration 636 636
No Code Available 581 581
Joint Laxity 536 536
Insufficient Information 461 461
No Patient Involvement 301 301
Bone Fracture(s) 299 299
Swelling 293 293
Failure of Implant 270 270
Fall 267 267
Swelling/ Edema 255 255
Scar Tissue 233 233
Limited Mobility Of The Implanted Joint 173 173
Adhesion(s) 132 132
Joint Dislocation 118 118
Inflammation 112 112
Reaction 90 90
Osteolysis 84 84
Muscular Rigidity 79 79
Discomfort 72 72
Fibrosis 63 63
Hematoma 57 57
Synovitis 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 50
Damage to Ligament(s) 48 48
Numbness 45 45
Bacterial Infection 40 40
Wound Dehiscence 39 39
Joint Swelling 38 38
Tissue Damage 37 37
Thrombosis/Thrombus 36 36
Muscle/Tendon Damage 31 31
Arthritis 30 30
Nerve Damage 30 30
Aspiration/Inhalation 29 29
Hypersensitivity/Allergic reaction 28 28
Unspecified Tissue Injury 26 26
Embolism 25 25
Rupture 23 23
Device Embedded In Tissue or Plaque 23 23
Impaired Healing 22 22
Burning Sensation 21 21
Cyst(s) 21 21
Foreign Body Reaction 21 21
Foreign Body In Patient 20 20
Fluid Discharge 18 18
Patient Problem/Medical Problem 17 17
Necrosis 17 17
Arthralgia 16 16
Osteopenia/ Osteoporosis 16 16
Metal Related Pathology 16 16
Limb Fracture 15 15
Implant Pain 15 15
Thrombosis 15 15
Muscle Weakness 15 15
Hemorrhage/Bleeding 15 15
Pulmonary Embolism 14 14
Subluxation 14 14
Embolism/Embolus 14 14
Ossification 13 13
Death 13 13
Cellulitis 13 13
Sepsis 13 13
Weakness 13 13
Joint Disorder 13 13
Deformity/ Disfigurement 10 10
Erythema 10 10
Bruise/Contusion 9 9
Rash 9 9
Skin Discoloration 9 9
Sleep Dysfunction 7 7
Edema 7 7
Abscess 6 6
Rheumatoid Arthritis 6 6
Fever 6 6
Tissue Breakdown 6 6
Increased Sensitivity 6 6
Unequal Limb Length 6 6
Unspecified Musculoskeletal problem 5 5
Joint Contracture 5 5
Hyperextension 5 5
Peripheral Nervous Injury 5 5
Hypoxia 5 5
Neuropathy 5 5
Erosion 5 5
Post Operative Wound Infection 5 5
Respiratory Acidosis 4 4
Respiratory Failure 4 4
Weight Changes 4 4
Scar Excision 4 4
Complaint, Ill-Defined 4 4
Toxicity 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-22-2024
2 Biomet, Inc. II Oct-08-2020
3 Biomet, Inc. II May-28-2020
4 Biomet, Inc. II Mar-25-2016
5 DePuy Orthopaedics, Inc. II Mar-29-2024
6 DePuy Orthopaedics, Inc. II Jul-20-2015
7 DePuy Orthopaedics, Inc. I Feb-15-2013
8 Encore Medical, LP II Dec-07-2023
9 Encore Medical, LP II Nov-07-2023
10 Encore Medical, LP II Apr-12-2023
11 Encore Medical, LP II Oct-07-2020
12 Howmedica Osteonics Corp. II Mar-06-2024
13 Howmedica Osteonics Corp. II May-30-2023
14 Howmedica Osteonics Corp. II Mar-08-2021
15 Howmedica Osteonics Corp. II Sep-27-2019
16 Howmedica Osteonics Corp. II Apr-24-2018
17 Howmedica Osteonics Corp. II Apr-20-2018
18 MicroPort Orthopedics Inc. I Sep-08-2016
19 Smith & Nephew, Inc. II Jan-28-2020
20 Smith & Nephew, Inc. II Oct-22-2018
21 Smith & Nephew, Inc. II Jun-11-2018
22 Smith & Nephew, Inc. II May-21-2018
23 Stryker Howmedica Osteonics Corp. II Sep-13-2016
24 Stryker Howmedica Osteonics Corp. II Aug-11-2016
25 Stryker Howmedica Osteonics Corp. II Aug-14-2015
26 Stryker Howmedica Osteonics Corp. II Mar-16-2015
27 Stryker Howmedica Osteonics Corp. I Apr-12-2013
28 Stryker Howmedica Osteonics Corp. II Jan-08-2009
29 Wright Medical Technology Inc III Dec-08-2009
30 Zimmer Biomet, Inc. II Mar-14-2018
31 Zimmer Biomet, Inc. II Mar-14-2018
32 Zimmer Biomet, Inc. II Apr-25-2017
33 Zimmer Biomet, Inc. II Jun-07-2016
34 Zimmer Biomet, Inc. II Feb-22-2016
35 Zimmer Inc. II Jul-27-2012
36 Zimmer Inc. II May-10-2011
37 Zimmer Inc. II Apr-14-2011
38 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
39 Zimmer Trabecular Metal Technology, Inc. II Mar-26-2015
40 Zimmer, Inc. II Mar-12-2015
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