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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/polymer, cemented
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
SIGNATURE ORTHOPAEDICS PTY LTD.
  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 3

MDR Year MDR Reports MDR Events
2017 6144 6144
2018 6739 6739
2019 7414 7414
2020 4033 4033
2021 3201 3201
2022 1459 1459

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7594 7594
Adverse Event Without Identified Device or Use Problem 7087 7087
Device Dislodged or Dislocated 4294 4294
Naturally Worn 2222 2222
Appropriate Term/Code Not Available 1574 1574
Fracture 1135 1135
Break 965 965
Corroded 957 957
Loss of Osseointegration 686 686
Degraded 502 502
Material Erosion 442 442
Unstable 415 415
Metal Shedding Debris 395 395
Noise, Audible 390 390
Migration 352 352
Loose or Intermittent Connection 343 343
Migration or Expulsion of Device 333 333
Osseointegration Problem 329 329
Loosening of Implant Not Related to Bone-Ingrowth 299 299
Material Disintegration 292 292
Biocompatibility 267 267
Difficult to Insert 263 263
Loss of or Failure to Bond 247 247
Detachment of Device or Device Component 247 247
Malposition of Device 229 229
Material Deformation 191 191
Device Operates Differently Than Expected 186 186
Packaging Problem 182 182
Nonstandard Device 163 163
Mechanical Problem 116 116
Device Contaminated During Manufacture or Shipping 97 97
Material Twisted/Bent 89 89
Use of Device Problem 84 84
Unintended Movement 75 75
Connection Problem 74 74
Difficult to Remove 73 73
Tear, Rip or Hole in Device Packaging 72 72
Device Markings/Labelling Problem 63 63
Disassembly 62 62
Positioning Failure 58 58
Patient Device Interaction Problem 58 58
Inadequacy of Device Shape and/or Size 56 56
Crack 53 53
Fitting Problem 50 50
Device-Device Incompatibility 48 48
Positioning Problem 47 47
Material Fragmentation 43 43
Incomplete or Inadequate Connection 42 42
No Apparent Adverse Event 39 39
Material Integrity Problem 38 38
Separation Failure 38 38
Difficult To Position 38 38
Mechanical Jam 37 37
Device Slipped 34 34
Failure to Osseointegrate 33 33
Patient-Device Incompatibility 33 33
Defective Device 32 32
Off-Label Use 30 30
Physical Resistance/Sticking 27 27
Device Packaging Compromised 25 25
Device Inoperable 24 24
Device Contamination with Chemical or Other Material 23 23
Material Discolored 23 23
Separation Problem 22 22
Detachment Of Device Component 21 21
Deformation Due to Compressive Stress 21 21
Device Damaged Prior to Use 20 20
Device Difficult to Setup or Prepare 19 19
Component Missing 18 18
Scratched Material 18 18
Delivered as Unsterile Product 17 17
Improper or Incorrect Procedure or Method 17 17
Failure To Adhere Or Bond 17 17
Difficult or Delayed Positioning 16 16
Premature Separation 16 16
Defective Component 15 15
Device Damaged by Another Device 15 15
Manufacturing, Packaging or Shipping Problem 14 14
Material Separation 14 14
Dull, Blunt 12 12
Bent 11 11
Compatibility Problem 10 10
Flaked 9 9
Device Appears to Trigger Rejection 9 9
Unsealed Device Packaging 8 8
Entrapment of Device 8 8
Misassembled 8 8
Difficult or Delayed Separation 8 8
Inaccurate Information 7 7
Disconnection 7 7
Microbial Contamination of Device 7 7
Contamination /Decontamination Problem 7 7
Difficult to Open or Remove Packaging Material 6 6
Peeled/Delaminated 6 6
Contamination 5 5
Material Protrusion/Extrusion 5 5
Activation, Positioning or SeparationProblem 5 5
Device Disinfection Or Sterilization Issue 5 5
Failure to Align 5 5
Expiration Date Error 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8003 8003
No Code Available 7147 7147
Joint Dislocation 3745 3745
Injury 3698 3698
Unspecified Infection 3349 3349
No Information 3170 3170
Test Result 1945 1945
Foreign Body Reaction 1922 1922
Inflammation 1807 1807
Discomfort 1538 1538
Tissue Damage 1512 1512
Reaction 1362 1362
Osteolysis 1157 1157
Bone Fracture(s) 1113 1113
Not Applicable 1107 1107
No Clinical Signs, Symptoms or Conditions 995 995
No Known Impact Or Consequence To Patient 980 980
Limited Mobility Of The Implanted Joint 928 928
Inadequate Osseointegration 875 875
No Consequences Or Impact To Patient 865 865
Ambulation Difficulties 864 864
Failure of Implant 766 766
Host-Tissue Reaction 737 737
Hypersensitivity/Allergic reaction 674 674
Loss of Range of Motion 624 624
Insufficient Information 571 571
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 501 501
Necrosis 399 399
Metal Related Pathology 374 374
Fall 373 373
Swelling 328 328
Edema 319 319
Distress 311 311
Joint Disorder 311 311
Joint Laxity 277 277
Weakness 265 265
No Patient Involvement 254 254
Hematoma 232 232
Hip Fracture 214 214
Ossification 211 211
Adhesion(s) 186 186
Synovitis 182 182
Scar Tissue 158 158
Impaired Healing 144 144
Wound Dehiscence 140 140
Cyst(s) 140 140
Deformity/ Disfigurement 139 139
Death 138 138
Thrombosis 135 135
Unspecified Tissue Injury 132 132
Swelling/ Edema 128 128
Fatigue 126 126
Local Reaction 123 123
Pulmonary Embolism 122 122
Hemorrhage/Bleeding 112 112
Blood Loss 110 110
Muscular Rigidity 107 107
Anxiety 105 105
Bacterial Infection 92 92
Osteopenia/ Osteoporosis 91 91
Nerve Damage 81 81
Fever 77 77
Hypoesthesia 67 67
Fluid Discharge 66 66
Sepsis 62 62
Physical Asymmetry 60 60
Depression 56 56
Myocardial Infarction 51 51
Fibrosis 49 49
Foreign Body In Patient 46 46
Post Operative Wound Infection 46 46
Abscess 46 46
Erosion 44 44
Numbness 44 44
Headache 43 43
Rash 43 43
Cardiac Arrest 42 42
Toxicity 42 42
Device Embedded In Tissue or Plaque 38 38
Pocket Erosion 38 38
Scarring 37 37
Erythema 36 36
Anemia 35 35
Renal Failure 35 35
Muscle/Tendon Damage 33 33
Neuropathy 32 32
Memory Loss/Impairment 30 30
Infarction, Cerebral 30 30
Irritation 29 29
Thrombosis/Thrombus 27 27
Seroma 26 26
Cellulitis 26 26
Encephalopathy 24 24
Calcium Deposits/Calcification 23 23
Arthritis 23 23
Skin Irritation 23 23
Patient Problem/Medical Problem 23 23
Joint Swelling 23 23
Complaint, Ill-Defined 23 23
Heart Failure 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 Corin Ltd II Aug-31-2022
5 Corin Ltd II Aug-09-2022
6 DePuy Orthopaedics, Inc. II Jun-10-2021
7 Exactech, Inc. II Sep-09-2022
8 Exactech, Inc. II Jan-17-2017
9 Howmedica Osteonics Corp. II Jan-15-2020
10 Howmedica Osteonics Corp. II Oct-11-2018
11 MicroPort Orthopedics Inc. II Jun-02-2022
12 Smith & Nephew, Inc. II May-09-2018
13 Smith & Nephew, Inc. II Jan-11-2017
14 Zimmer Biomet, Inc. II Nov-02-2020
15 Zimmer Biomet, Inc. II Aug-09-2019
16 Zimmer Biomet, Inc. II Dec-04-2018
17 Zimmer Biomet, Inc. II Aug-14-2018
18 Zimmer Biomet, Inc. II Apr-27-2018
19 Zimmer Biomet, Inc. II Mar-14-2018
20 Zimmer Biomet, Inc. II Mar-14-2018
21 Zimmer Biomet, Inc. II Dec-29-2017
22 Zimmer Biomet, Inc. II Mar-27-2017
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