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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 7

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 1264 1264
2024 409 409

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2780 2780
Adverse Event Without Identified Device or Use Problem 2487 2487
Unstable 1241 1241
Fracture 1093 1093
Break 833 833
Loss of Osseointegration 424 424
Naturally Worn 267 267
Osseointegration Problem 243 243
Difficult to Insert 243 243
Loose or Intermittent Connection 203 203
Material Integrity Problem 203 203
Device Operates Differently Than Expected 197 197
Detachment of Device or Device Component 191 191
Loosening of Implant Not Related to Bone-Ingrowth 186 186
Noise, Audible 181 181
Device Dislodged or Dislocated 179 179
Malposition of Device 175 175
Appropriate Term/Code Not Available 175 175
Degraded 163 163
Migration or Expulsion of Device 162 162
Mechanical Problem 159 159
Device Contamination with Chemical or Other Material 138 138
Migration 134 134
Packaging Problem 127 127
Material Deformation 111 111
Device Slipped 102 102
Crack 92 92
Manufacturing, Packaging or Shipping Problem 91 91
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 61 61
Inadequacy of Device Shape and/or Size 59 59
Fitting Problem 57 57
Scratched Material 52 52
Loss of or Failure to Bond 51 51
Detachment Of Device Component 49 49
Positioning Failure 47 47
Mechanical Jam 47 47
Material Discolored 46 46
Patient Device Interaction Problem 46 46
Device Packaging Compromised 45 45
Corroded 36 36
Device Damaged Prior to Use 32 32
Nonstandard Device 31 31
Tear, Rip or Hole in Device Packaging 30 30
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
Device Difficult to Setup or Prepare 18 18
Contamination /Decontamination Problem 18 18
Mechanics Altered 17 17
Difficult to Remove 17 17
No Apparent Adverse Event 17 17
Incomplete or Inadequate Connection 17 17
Delivered as Unsterile Product 16 16
Peeled/Delaminated 16 16
Material Distortion 16 16
Difficult to Open or Remove Packaging Material 15 15
Defective Device 15 15
Metal Shedding Debris 15 15
Device-Device Incompatibility 14 14
Material Disintegration 14 14
Difficult To Position 13 13
Device Inoperable 13 13
Device Handling Problem 13 13
Residue After Decontamination 12 12
Patient-Device Incompatibility 12 12
Pitted 12 12
Device Reprocessing Problem 12 12
Contamination 11 11
Disassembly 11 11
Melted 11 11
Device Markings/Labelling Problem 10 10
Defective Component 9 9
Flaked 9 9
Entrapment of Device 8 8
Collapse 8 8
Shipping Damage or Problem 7 7
Delamination 7 7
Activation, Positioning or Separation Problem 7 7
Device Disinfection Or Sterilization Issue 7 7
Device Damaged by Another Device 7 7
Compatibility Problem 6 6
Material Twisted/Bent 6 6
Dent in Material 6 6
Physical Resistance/Sticking 6 6
Torn Material 5 5
Product Quality Problem 5 5
Material Too Rigid or Stiff 5 5
Component Incompatible 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2845 2845
Injury 2476 2476
No Clinical Signs, Symptoms or Conditions 1249 1249
Unspecified Infection 1196 1196
No Known Impact Or Consequence To Patient 893 893
No Consequences Or Impact To Patient 749 749
Ambulation Difficulties 684 684
Loss of Range of Motion 657 657
No Information 643 643
Inadequate Osseointegration 633 633
No Code Available 581 581
Joint Laxity 527 527
Insufficient Information 443 443
No Patient Involvement 301 301
Swelling 293 293
Bone Fracture(s) 293 293
Failure of Implant 269 269
Fall 263 263
Swelling/ Edema 245 245
Scar Tissue 226 226
Limited Mobility Of The Implanted Joint 173 173
Adhesion(s) 126 126
Joint Dislocation 117 117
Inflammation 111 111
Reaction 90 90
Osteolysis 82 82
Muscular Rigidity 79 79
Discomfort 70 70
Fibrosis 62 62
Hematoma 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 50
Synovitis 49 49
Damage to Ligament(s) 48 48
Numbness 44 44
Wound Dehiscence 39 39
Bacterial Infection 39 39
Joint Swelling 38 38
Tissue Damage 37 37
Thrombosis/Thrombus 36 36
Arthritis 30 30
Nerve Damage 30 30
Aspiration/Inhalation 29 29
Muscle/Tendon Damage 29 29
Hypersensitivity/Allergic reaction 28 28
Embolism 25 25
Rupture 23 23
Device Embedded In Tissue or Plaque 23 23
Unspecified Tissue Injury 22 22
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 16 16
Arthralgia 16 16
Osteopenia/ Osteoporosis 15 15
Thrombosis 15 15
Muscle Weakness 15 15
Implant Pain 15 15
Limb Fracture 15 15
Metal Related Pathology 15 15
Embolism/Embolus 14 14
Hemorrhage/Bleeding 14 14
Pulmonary Embolism 14 14
Ossification 13 13
Death 13 13
Cellulitis 13 13
Weakness 13 13
Joint Disorder 13 13
Subluxation 13 13
Sepsis 12 12
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
Increased Sensitivity 6 6
Unequal Limb Length 6 6
Unspecified Musculoskeletal problem 5 5
Hyperextension 5 5
Peripheral Nervous Injury 5 5
Tissue Breakdown 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
Scarring 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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