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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 6736 6736
2019 7413 7413
2020 4026 4026
2021 2835 2835

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9228 9228
Adverse Event Without Identified Device or Use Problem 6498 6498
Device Dislodged or Dislocated 4611 4611
Naturally Worn 2534 2534
Appropriate Term/Code Not Available 2297 2297
Fracture 1185 1185
Corroded 1095 1095
Break 1050 1050
Loss of Osseointegration 813 813
Metal Shedding Debris 569 569
Noise, Audible 459 459
Degraded 452 452
Material Erosion 449 449
Migration or Expulsion of Device 423 423
Unstable 419 419
Material Disintegration 379 379
Loose or Intermittent Connection 374 374
Migration 340 340
Osseointegration Problem 320 320
Malposition of Device 302 302
Loss of or Failure to Bond 284 284
Loosening of Implant Not Related to Bone-Ingrowth 265 265
Biocompatibility 264 264
Difficult to Insert 240 240
Device Operates Differently Than Expected 208 208
Detachment of Device or Device Component 202 202
Material Deformation 202 202
Nonstandard Device 186 186
Packaging Problem 164 164
Mechanical Problem 130 130
Disassembly 110 110
Material Twisted/Bent 85 85
Device Contaminated During Manufacture or Shipping 83 83
Use of Device Problem 76 76
Difficult to Remove 75 75
Connection Problem 75 75
Unintended Movement 71 71
Tear, Rip or Hole in Device Packaging 69 69
Material Integrity Problem 66 66
Device Markings/Labelling Problem 65 65
Inadequacy of Device Shape and/or Size 64 64
Crack 59 59
Positioning Problem 57 57
Patient Device Interaction Problem 53 53
Device-Device Incompatibility 52 52
Fitting Problem 52 52
Device Slipped 52 52
Device Contamination with Chemical or Other Material 51 51
Positioning Failure 50 50
Separation Failure 46 46
Material Fragmentation 45 45
Difficult To Position 44 44
Detachment Of Device Component 42 42
Incomplete or Inadequate Connection 42 42
Failure To Adhere Or Bond 39 39
Patient-Device Incompatibility 39 39
No Apparent Adverse Event 38 38
Mechanical Jam 37 37
Defective Device 33 33
Failure to Osseointegrate 32 32
Device Packaging Compromised 27 27
Physical Resistance/Sticking 27 27
Device Inoperable 24 24
Device Damaged Prior to Use 22 22
Material Discolored 22 22
Separation Problem 22 22
Material Separation 21 21
Off-Label Use 21 21
Component Missing 21 21
Deformation Due to Compressive Stress 21 21
Device Difficult to Setup or Prepare 18 18
Scratched Material 18 18
Defective Component 17 17
Compatibility Problem 17 17
Device Damaged by Another Device 16 16
Improper or Incorrect Procedure or Method 16 16
Difficult or Delayed Positioning 16 16
Premature Separation 16 16
Delivered as Unsterile Product 14 14
Bent 12 12
Manufacturing, Packaging or Shipping Problem 12 12
Dull, Blunt 12 12
Entrapment of Device 10 10
Flaked 9 9
Misassembled 9 9
Device Appears to Trigger Rejection 8 8
Disconnection 8 8
Component or Accessory Incompatibility 8 8
Contamination /Decontamination Problem 7 7
Microbial Contamination of Device 7 7
Unsealed Device Packaging 7 7
Difficult or Delayed Separation 7 7
Misconnection 6 6
Contamination 6 6
Peeled/Delaminated 5 5
Failure to Align 5 5
Material Protrusion/Extrusion 5 5
Activation, Positioning or SeparationProblem 5 5
Device Disinfection Or Sterilization Issue 5 5
Difficult to Open or Remove Packaging Material 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9042 9042
No Code Available 7883 7883
No Information 4368 4368
Injury 3936 3936
Joint Dislocation 3640 3640
Unspecified Infection 3445 3445
Foreign Body Reaction 2159 2159
Discomfort 1987 1987
Test Result 1981 1981
Inflammation 1937 1937
Tissue Damage 1658 1658
Reaction 1462 1462
Osteolysis 1328 1328
Bone Fracture(s) 1196 1196
Not Applicable 1150 1150
Limited Mobility Of The Implanted Joint 1131 1131
Host-Tissue Reaction 1089 1089
No Known Impact Or Consequence To Patient 1066 1066
No Consequences Or Impact To Patient 936 936
Inadequate Osseointegration 845 845
Ambulation Difficulties 838 838
No Clinical Signs, Symptoms or Conditions 823 823
Hypersensitivity/Allergic reaction 654 654
Loss of Range of Motion 626 626
Failure of Implant 589 589
Necrosis 429 429
Insufficient Information 416 416
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 391 391
Fall 366 366
Swelling 364 364
Edema 348 348
Joint Disorder 334 334
Weakness 284 284
Distress 272 272
No Patient Involvement 258 258
Hematoma 233 233
Hip Fracture 222 222
Ossification 213 213
Synovitis 213 213
Metal Related Pathology 193 193
Adhesion(s) 173 173
Death 157 157
Cyst(s) 152 152
Impaired Healing 141 141
Thrombosis 139 139
Wound Dehiscence 136 136
Muscular Rigidity 135 135
Joint Laxity 134 134
Deformity/ Disfigurement 133 133
Local Reaction 123 123
Scar Tissue 121 121
Blood Loss 120 120
Fatigue 118 118
Pulmonary Embolism 116 116
Anxiety 111 111
Hemorrhage/Bleeding 93 93
Bacterial Infection 91 91
Osteopenia/ Osteoporosis 88 88
Toxicity 81 81
Nerve Damage 72 72
Hypoesthesia 71 71
Depression 64 64
Swelling/ Edema 64 64
Sepsis 64 64
Fever 52 52
Fibrosis 51 51
Unspecified Tissue Injury 50 50
Joint Swelling 50 50
Headache 49 49
Myocardial Infarction 49 49
Cardiac Arrest 46 46
Foreign Body In Patient 46 46
Device Embedded In Tissue or Plaque 44 44
Erosion 44 44
Abscess 42 42
Irritation 39 39
Scarring 39 39
Fluid Discharge 39 39
Rash 38 38
Pocket Erosion 36 36
Numbness 36 36
Post Operative Wound Infection 35 35
Physical Asymmetry 35 35
Renal Failure 34 34
Skin Irritation 33 33
Anemia 33 33
Infarction, Cerebral 32 32
Neuropathy 31 31
Memory Loss/Impairment 31 31
Cellulitis 27 27
Complaint, Ill-Defined 26 26
Burning Sensation 25 25
Heart Failure 24 24
Patient Problem/Medical Problem 24 24
Embolism 24 24
Encephalopathy 24 24
Arthritis 24 24
Calcium Deposits/Calcification 24 24
Pneumonia 24 24
Seroma 24 24

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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