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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Product CodeKWY
Regulation Number 888.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY FRANCE S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
G21, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTS INTERNATIONAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNLIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.,
  SUBSTANTIALLY EQUIVALENT 1
TGM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1059 1059
2015 1218 1218
2016 883 883
2017 830 830
2018 1380 1380
2019 1530 1530
2020 1260 1260
2021 276 276
2022 208 208
2023 177 177
2024 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2555 2555
Adverse Event Without Identified Device or Use Problem 1963 1963
Device Dislodged or Dislocated 1590 1590
Naturally Worn 724 724
Appropriate Term/Code Not Available 658 658
Fracture 292 292
Loss of Osseointegration 271 271
Corroded 186 186
Noise, Audible 162 162
Metal Shedding Debris 135 135
Difficult to Insert 126 126
Material Erosion 101 101
Break 92 92
Migration 91 91
Migration or Expulsion of Device 85 85
Loose or Intermittent Connection 80 80
Malposition of Device 68 68
Loss of or Failure to Bond 68 68
Nonstandard Device 61 61
Disassembly 49 49
Unstable 49 49
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Detachment of Device or Device Component 42 42
Degraded 42 42
Biocompatibility 40 40
Osseointegration Problem 39 39
Fitting Problem 38 38
Device Contamination with Chemical or Other Material 36 36
Use of Device Problem 32 32
Unintended Movement 28 28
Device Operates Differently Than Expected 27 27
Material Disintegration 26 26
Device Slipped 26 26
Device Contaminated During Manufacture or Shipping 23 23
Patient-Device Incompatibility 23 23
Difficult to Remove 20 20
Delivered as Unsterile Product 20 20
Inadequacy of Device Shape and/or Size 18 18
Detachment Of Device Component 18 18
Packaging Problem 18 18
Mechanical Problem 17 17
Patient Device Interaction Problem 17 17
Material Integrity Problem 17 17
Device-Device Incompatibility 13 13
Separation Failure 12 12
Positioning Failure 12 12
Positioning Problem 11 11
Failure to Osseointegrate 10 10
Compatibility Problem 9 9
No Apparent Adverse Event 9 9
Device Damaged Prior to Use 9 9
Off-Label Use 9 9
Material Separation 9 9
Crack 8 8
Difficult To Position 8 8
Improper or Incorrect Procedure or Method 7 7
Bent 6 6
Scratched Material 6 6
Device Markings/Labelling Problem 5 5
Mechanical Jam 5 5
Material Deformation 5 5
Tear, Rip or Hole in Device Packaging 5 5
Connection Problem 5 5
Contamination /Decontamination Problem 4 4
Device Difficult to Setup or Prepare 4 4
Structural Problem 3 3
Component Missing 3 3
Activation, Positioning or Separation Problem 3 3
Failure To Adhere Or Bond 3 3
Expiration Date Error 3 3
Physical Resistance/Sticking 3 3
Device Packaging Compromised 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Disinfection Or Sterilization Issue 3 3
Device Expiration Issue 3 3
Defective Device 3 3
Shelf Life Exceeded 2 2
Separation Problem 2 2
Dull, Blunt 2 2
Material Protrusion/Extrusion 2 2
Device Damaged by Another Device 2 2
Material Too Rigid or Stiff 2 2
Incorrect Device Or Component Shipped 2 2
Human-Device Interface Problem 2 2
Material Twisted/Bent 2 2
Material Discolored 2 2
Contamination 2 2
Misconnection 2 2
Deformation Due to Compressive Stress 2 2
Difficult or Delayed Positioning 2 2
Misassembled 2 2
High Test Results 1 1
Component Misassembled 1 1
Shipping Damage or Problem 1 1
Delamination 1 1
Gradient Increase 1 1
Device Abrasion From Instrument Or Another Object 1 1
Incorrect Measurement 1 1
Material Split, Cut or Torn 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3282 3283
No Code Available 3025 3028
No Information 1213 1213
Joint Dislocation 1094 1095
Unspecified Infection 1057 1058
Foreign Body Reaction 625 625
Test Result 552 552
Injury 471 471
Discomfort 466 466
Osteolysis 418 418
Tissue Damage 380 380
Bone Fracture(s) 322 322
Host-Tissue Reaction 312 312
Not Applicable 307 307
Inflammation 304 304
Limited Mobility Of The Implanted Joint 248 248
No Consequences Or Impact To Patient 210 210
Reaction 196 196
Loss of Range of Motion 194 194
Hypersensitivity/Allergic reaction 192 192
No Known Impact Or Consequence To Patient 165 165
Ambulation Difficulties 163 163
Inadequate Osseointegration 150 150
No Clinical Signs, Symptoms or Conditions 127 127
Toxicity 127 127
Failure of Implant 126 126
Fall 111 111
Insufficient Information 107 107
Necrosis 106 106
Swelling 103 103
Edema 94 94
Hematoma 91 91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 84 84
Weakness 69 69
Thrombosis 65 65
Distress 56 56
Cyst(s) 53 53
Joint Laxity 51 51
Pulmonary Embolism 50 50
No Patient Involvement 50 50
Adhesion(s) 45 45
Metal Related Pathology 41 41
Synovitis 40 40
Ossification 39 39
Fatigue 39 39
Scar Tissue 37 37
Hip Fracture 36 36
Impaired Healing 35 35
Joint Disorder 30 30
Death 29 29
Hemorrhage/Bleeding 28 28
Local Reaction 26 26
Blood Loss 24 24
Anxiety 24 24
Nerve Damage 22 22
Swelling/ Edema 21 21
Deformity/ Disfigurement 21 21
Osteopenia/ Osteoporosis 20 20
Muscular Rigidity 18 18
Unspecified Tissue Injury 18 18
Fever 17 17
Depression 17 17
Complaint, Ill-Defined 16 16
Post Operative Wound Infection 16 16
Joint Swelling 15 15
Wound Dehiscence 14 14
Bacterial Infection 13 13
Dyspnea 13 13
Fluid Discharge 13 13
Erosion 12 12
Sepsis 12 12
Foreign Body In Patient 11 11
Aspiration/Inhalation 10 10
Arthritis 10 10
Muscle Weakness 10 10
Fibrosis 10 10
Seroma 10 10
Physical Asymmetry 10 10
Scarring 9 9
Myocardial Infarction 9 9
Irritation 9 9
Stroke/CVA 9 9
Arthralgia 8 8
Pocket Erosion 8 8
Sleep Dysfunction 8 8
Muscle/Tendon Damage 8 8
Disability 8 8
Patient Problem/Medical Problem 8 8
Cardiac Arrest 8 8
Rash 8 8
Memory Loss/Impairment 8 8
Skin Irritation 8 8
Abscess 7 7
Headache 7 7
Implant Pain 7 7
Vertigo 7 7
Nausea 6 6
Hearing Impairment 6 6
Tinnitus 6 6
Neurological Deficit/Dysfunction 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Omni Life Science II Sep-10-2009
3 Ortho Development Corporation II Aug-17-2014
4 Ortho Development Corporation II Nov-03-2010
5 Ortho Development Corporation II Oct-28-2009
6 Orthopedic Alliance LLC II May-24-2013
7 Smith & Nephew, Inc. II Nov-03-2016
8 Zimmer Biomet, Inc. II Nov-22-2019
9 Zimmer Biomet, Inc. II Nov-07-2018
10 Zimmer Biomet, Inc. II Mar-14-2018
11 Zimmer Biomet, Inc. II Feb-15-2018
12 Zimmer Biomet, Inc. II Feb-22-2016
13 Zimmer Manufacturing B.V. II Mar-12-2016
14 Zimmer, Inc. II Feb-20-2014
15 Zimmer, Inc. II Oct-25-2013
16 Zimmer, Inc. II Nov-20-2012
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