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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 6737 6737
2019 7414 7414
2020 4026 4026
2021 2363 2363

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9219 9219
Adverse Event Without Identified Device or Use Problem 6282 6282
Device Dislodged or Dislocated 4513 4513
Naturally Worn 2514 2514
Appropriate Term/Code Not Available 2268 2268
Fracture 1161 1161
Corroded 1075 1075
Break 1044 1044
Loss of Osseointegration 811 811
Metal Shedding Debris 569 569
Noise, Audible 452 452
Material Erosion 441 441
Degraded 438 438
Migration or Expulsion of Device 423 423
Unstable 409 409
Material Disintegration 379 379
Loose or Intermittent Connection 371 371
Migration 331 331
Osseointegration Problem 301 301
Malposition of Device 300 300
Loss of or Failure to Bond 273 273
Biocompatibility 263 263
Loosening of Implant Not Related to Bone-Ingrowth 256 256
Difficult to Insert 236 236
Device Operates Differently Than Expected 208 208
Material Deformation 201 201
Detachment of Device or Device Component 191 191
Nonstandard Device 186 186
Packaging Problem 154 154
Mechanical Problem 128 128
Disassembly 110 110
Material Twisted/Bent 85 85
Connection Problem 75 75
Difficult to Remove 74 74
Device Contaminated During Manufacture or Shipping 73 73
Use of Device Problem 72 72
Tear, Rip or Hole in Device Packaging 67 67
Unintended Movement 66 66
Device Markings/Labelling Problem 65 65
Inadequacy of Device Shape and/or Size 63 63
Material Integrity Problem 62 62
Crack 59 59
Positioning Problem 57 57
Fitting Problem 52 52
Device Slipped 52 52
Device-Device Incompatibility 51 51
Device Contamination with Chemical or Other Material 51 51
Positioning Failure 50 50
Separation Failure 46 46
Material Fragmentation 44 44
Difficult To Position 44 44
Patient Device Interaction Problem 44 44
Detachment Of Device Component 42 42
Incomplete or Inadequate Connection 42 42
Failure To Adhere Or Bond 39 39
No Apparent Adverse Event 38 38
Mechanical Jam 37 37
Patient-Device Incompatibility 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
Material Discolored 22 22
Device Damaged Prior to Use 22 22
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Component Missing 21 21
Material Separation 21 21
Off-Label Use 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
Premature Separation 16 16
Difficult or Delayed Positioning 16 16
Improper or Incorrect Procedure or Method 16 16
Delivered as Unsterile Product 14 14
Dull, Blunt 12 12
Bent 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Entrapment of Device 10 10
Misassembled 9 9
Flaked 9 9
Disconnection 8 8
Device Appears to Trigger Rejection 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
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
Failure to Align 5 5
Activation, Positioning or SeparationProblem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8935 8935
No Code Available 7884 7884
No Information 4368 4368
Injury 3936 3936
Joint Dislocation 3546 3546
Unspecified Infection 3397 3397
Foreign Body Reaction 2120 2120
Test Result 1981 1981
Discomfort 1980 1980
Inflammation 1927 1927
Tissue Damage 1658 1658
Reaction 1464 1464
Osteolysis 1302 1302
Bone Fracture(s) 1186 1186
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 936 936
Inadequate Osseointegration 823 823
Ambulation Difficulties 803 803
No Clinical Signs, Symptoms or Conditions 774 774
Hypersensitivity/Allergic reaction 645 645
Loss of Range of Motion 610 610
Failure of Implant 525 525
Necrosis 418 418
Insufficient Information 367 367
Swelling 365 365
Edema 348 348
Fall 347 347
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 342 342
Joint Disorder 334 334
Weakness 284 284
Distress 267 267
No Patient Involvement 258 258
Hematoma 230 230
Hip Fracture 222 222
Synovitis 209 209
Ossification 207 207
Adhesion(s) 172 172
Death 157 157
Cyst(s) 149 149
Metal Related Pathology 147 147
Thrombosis 139 139
Impaired Healing 139 139
Wound Dehiscence 136 136
Deformity/ Disfigurement 133 133
Muscular Rigidity 132 132
Local Reaction 123 123
Blood Loss 120 120
Pulmonary Embolism 116 116
Fatigue 113 113
Anxiety 111 111
Scar Tissue 111 111
Joint Laxity 110 110
Bacterial Infection 90 90
Hemorrhage/Bleeding 89 89
Osteopenia/ Osteoporosis 82 82
Toxicity 81 81
Hypoesthesia 71 71
Nerve Damage 70 70
Depression 64 64
Sepsis 64 64
Fever 52 52
Fibrosis 51 51
Joint Swelling 50 50
Headache 49 49
Myocardial Infarction 47 47
Swelling/ Edema 47 47
Foreign Body In Patient 46 46
Cardiac Arrest 46 46
Device Embedded In Tissue or Plaque 44 44
Erosion 42 42
Abscess 41 41
Irritation 39 39
Scarring 39 39
Unspecified Tissue Injury 38 38
Rash 38 38
Numbness 36 36
Pocket Erosion 36 36
Post Operative Wound Infection 35 35
Fluid Discharge 35 35
Renal Failure 34 34
Skin Irritation 33 33
Anemia 32 32
Physical Asymmetry 32 32
Infarction, Cerebral 32 32
Neuropathy 31 31
Memory Loss/Impairment 30 30
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
Seroma 24 24
Arthritis 24 24
Calcium Deposits/Calcification 24 24
Encephalopathy 24 24
Tinnitus 23 23

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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