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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/polymer, cemented
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.,
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 3992 3992
2017 6144 6144
2018 6741 6741
2019 7414 7414
2020 4027 4027
2021 1636 1636

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9175 9175
Adverse Event Without Identified Device or Use Problem 5992 5992
Device Dislodged or Dislocated 4396 4396
Naturally Worn 2472 2472
Appropriate Term/Code Not Available 2253 2253
Fracture 1129 1129
Corroded 1065 1065
Break 1007 1007
Loss of Osseointegration 810 810
Metal Shedding Debris 569 569
Noise, Audible 443 443
Migration or Expulsion of Device 423 423
Material Erosion 419 419
Degraded 402 402
Unstable 399 399
Material Disintegration 379 379
Loose or Intermittent Connection 364 364
Migration 327 327
Malposition of Device 298 298
Osseointegration Problem 298 298
Loss of or Failure to Bond 269 269
Biocompatibility 261 261
Loosening of Implant Not Related to Bone-Ingrowth 241 241
Difficult to Insert 227 227
Device Operates Differently Than Expected 208 208
Material Deformation 199 199
Nonstandard Device 186 186
Detachment of Device or Device Component 161 161
Packaging Problem 141 141
Mechanical Problem 126 126
Disassembly 110 110
Material Twisted/Bent 79 79
Difficult to Remove 72 72
Use of Device Problem 71 71
Connection Problem 66 66
Device Markings/Labelling Problem 65 65
Tear, Rip or Hole in Device Packaging 64 64
Unintended Movement 64 64
Inadequacy of Device Shape and/or Size 62 62
Material Integrity Problem 61 61
Crack 57 57
Device Contaminated During Manufacture or Shipping 56 56
Positioning Problem 56 56
Device Contamination with Chemical or Other Material 51 51
Device Slipped 51 51
Device-Device Incompatibility 50 50
Fitting Problem 49 49
Difficult To Position 44 44
Positioning Failure 44 44
Separation Failure 44 44
Detachment Of Device Component 42 42
Failure To Adhere Or Bond 39 39
No Apparent Adverse Event 38 38
Patient Device Interaction Problem 38 38
Mechanical Jam 37 37
Patient-Device Incompatibility 36 36
Incomplete or Inadequate Connection 33 33
Failure to Osseointegrate 32 32
Material Fragmentation 31 31
Device Packaging Compromised 27 27
Physical Resistance/Sticking 26 26
Device Inoperable 24 24
Material Discolored 22 22
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Component Missing 21 21
Material Separation 21 21
Device Damaged Prior to Use 21 21
Defective Device 20 20
Scratched Material 18 18
Defective Component 17 17
Compatibility Problem 17 17
Device Difficult to Setup or Prepare 17 17
Device Damaged by Another Device 16 16
Difficult or Delayed Positioning 16 16
Improper or Incorrect Procedure or Method 16 16
Premature Separation 15 15
Off-Label Use 15 15
Delivered as Unsterile Product 14 14
Bent 12 12
Dull, Blunt 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Entrapment of Device 10 10
Misassembled 9 9
Flaked 9 9
Disconnection 8 8
Component or Accessory Incompatibility 8 8
Microbial Contamination of Device 7 7
Unsealed Device Packaging 7 7
Difficult or Delayed Separation 7 7
Device Appears to Trigger Rejection 7 7
Contamination /Decontamination Problem 7 7
Misconnection 6 6
Peeled/Delaminated 5 5
Contamination 5 5
Device Disinfection Or Sterilization Issue 5 5
Difficult to Open or Remove Packaging Material 5 5
Material Protrusion/Extrusion 5 5
Activation, Positioning or SeparationProblem 4 4
Failure to Align 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8803 8803
No Code Available 7886 7886
No Information 4369 4369
Injury 3937 3937
Joint Dislocation 3434 3434
Unspecified Infection 3345 3345
Foreign Body Reaction 2074 2074
Test Result 1984 1984
Discomfort 1968 1968
Inflammation 1914 1914
Tissue Damage 1658 1658
Reaction 1466 1466
Osteolysis 1275 1275
Bone Fracture(s) 1164 1164
Not Applicable 1150 1150
Limited Mobility Of The Implanted Joint 1131 1131
Host-Tissue Reaction 1090 1090
No Known Impact Or Consequence To Patient 1066 1066
No Consequences Or Impact To Patient 935 935
Inadequate Osseointegration 811 811
Ambulation Difficulties 759 759
Hypersensitivity/Allergic reaction 630 630
No Clinical Signs, Symptoms or Conditions 614 614
Loss of Range of Motion 589 589
Failure of Implant 467 467
Necrosis 407 407
Swelling 365 365
Edema 348 348
Joint Disorder 334 334
Fall 328 328
Weakness 284 284
Insufficient Information 281 281
Distress 261 261
No Patient Involvement 258 258
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 243 243
Hip Fracture 220 220
Hematoma 220 220
Synovitis 200 200
Ossification 199 199
Adhesion(s) 159 159
Death 157 157
Cyst(s) 148 148
Thrombosis 139 139
Wound Dehiscence 135 135
Deformity/ Disfigurement 132 132
Impaired Healing 132 132
Muscular Rigidity 130 130
Local Reaction 122 122
Blood Loss 120 120
Pulmonary Embolism 114 114
Fatigue 109 109
Anxiety 108 108
Scar Tissue 107 107
Metal Related Pathology 89 89
Bacterial Infection 83 83
Hemorrhage/Bleeding 82 82
Toxicity 81 81
Osteopenia/ Osteoporosis 78 78
Hypoesthesia 71 71
Joint Laxity 68 68
Nerve Damage 66 66
Depression 62 62
Sepsis 57 57
Fever 51 51
Joint Swelling 50 50
Fibrosis 50 50
Headache 49 49
Foreign Body In Patient 46 46
Cardiac Arrest 45 45
Myocardial Infarction 45 45
Device Embedded In Tissue or Plaque 44 44
Erosion 42 42
Abscess 41 41
Rash 40 40
Irritation 39 39
Scarring 39 39
Pocket Erosion 35 35
Numbness 34 34
Skin Irritation 33 33
Anemia 32 32
Infarction, Cerebral 32 32
Neuropathy 31 31
Renal Failure 31 31
Memory Loss/Impairment 30 30
Post Operative Wound Infection 30 30
Unspecified Tissue Injury 29 29
Swelling/ Edema 28 28
Fluid Discharge 28 28
Complaint, Ill-Defined 26 26
Burning Sensation 26 26
Cellulitis 26 26
Embolism 24 24
Heart Failure 24 24
Patient Problem/Medical Problem 24 24
Physical Asymmetry 24 24
Encephalopathy 24 24
Arthritis 23 23
Calcium Deposits/Calcification 23 23
Seroma 23 23
Tinnitus 22 22

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Oct-09-2020
3 Biomet, Inc. II May-28-2020
4 DePuy Orthopaedics, Inc. II Jun-10-2021
5 Exactech, Inc. II Jan-17-2017
6 Howmedica Osteonics Corp. II Jan-15-2020
7 Howmedica Osteonics Corp. II Oct-11-2018
8 Smith & Nephew, Inc. II May-09-2018
9 Smith & Nephew, Inc. II Jan-11-2017
10 Stryker Howmedica Osteonics Corp. II Nov-09-2016
11 Stryker Howmedica Osteonics Corp. II Aug-11-2016
12 Zimmer Biomet, Inc. II Nov-02-2020
13 Zimmer Biomet, Inc. II Aug-09-2019
14 Zimmer Biomet, Inc. II Dec-04-2018
15 Zimmer Biomet, Inc. II Aug-14-2018
16 Zimmer Biomet, Inc. II Apr-27-2018
17 Zimmer Biomet, Inc. II Mar-14-2018
18 Zimmer Biomet, Inc. II Mar-14-2018
19 Zimmer Biomet, Inc. II Dec-29-2017
20 Zimmer Biomet, Inc. II Mar-27-2017
21 Zimmer Biomet, Inc. II Feb-22-2016
22 Zimmer Manufacturing B.V. II May-16-2016
23 Zimmer Manufacturing B.V. II Mar-12-2016
24 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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