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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 AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  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
2019 7405 7405
2020 4015 4015
2021 3170 3170
2022 1980 1980
2023 1650 1795
2024 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6625 6675
Device Dislodged or Dislocated 2864 2864
Insufficient Information 2190 2270
Naturally Worn 1512 1512
Fracture 785 805
Break 726 726
Corroded 538 538
Degraded 522 522
Loss of Osseointegration 450 450
Material Erosion 378 378
Loosening of Implant Not Related to Bone-Ingrowth 358 361
Migration 333 339
Detachment of Device or Device Component 328 332
Appropriate Term/Code Not Available 326 326
Osseointegration Problem 299 299
Unstable 299 299
Noise, Audible 209 209
Loss of or Failure to Bond 198 198
Biocompatibility 189 189
Difficult to Insert 170 170
Loose or Intermittent Connection 137 137
Nonstandard Device 120 120
Packaging Problem 120 120
Malposition of Device 111 111
Use of Device Problem 104 104
Material Deformation 96 96
Material Twisted/Bent 89 89
Device Contaminated During Manufacture or Shipping 87 87
Patient Device Interaction Problem 78 78
Unintended Movement 72 72
Connection Problem 67 67
Positioning Failure 66 66
Tear, Rip or Hole in Device Packaging 63 63
Device Markings/Labelling Problem 58 58
Material Disintegration 53 53
Mechanical Problem 46 48
Difficult to Remove 42 42
Incomplete or Inadequate Connection 42 42
Migration or Expulsion of Device 38 42
Inadequacy of Device Shape and/or Size 36 36
Off-Label Use 35 35
Material Fragmentation 34 34
Crack 34 34
No Apparent Adverse Event 34 34
Fitting Problem 33 33
Mechanical Jam 32 32
Defective Device 31 31
Device-Device Incompatibility 30 30
Physical Resistance/Sticking 27 27
Failure to Osseointegrate 27 27
Positioning Problem 24 24
Patient-Device Incompatibility 20 20
Separation Failure 19 19
Device Appears to Trigger Rejection 18 18
Material Integrity Problem 18 18
Premature Separation 17 17
Defective Component 17 17
Delivered as Unsterile Product 17 17
Device Difficult to Setup or Prepare 15 15
Device Damaged Prior to Use 15 15
Difficult or Delayed Positioning 13 13
Manufacturing, Packaging or Shipping Problem 13 13
Improper or Incorrect Procedure or Method 11 11
Dull, Blunt 11 11
Scratched Material 10 10
Inaccurate Information 9 9
Material Separation 9 9
Component Missing 8 8
Flaked 8 8
Difficult or Delayed Separation 8 8
Illegible Information 7 7
Separation Problem 7 7
Material Discolored 7 7
Device Slipped 7 7
Failure to Advance 6 6
Peeled/Delaminated 6 6
Misassembled 6 6
Contamination /Decontamination Problem 6 6
Activation, Positioning or Separation Problem 6 6
Material Frayed 5 5
Expiration Date Error 5 5
Device Contamination with Chemical or Other Material 4 4
Compatibility Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Component Misassembled 3 3
Missing Information 3 3
Deformation Due to Compressive Stress 3 3
Problem with Sterilization 3 3
Shipping Damage or Problem 3 3
Misconnection 3 3
No Device Output 3 3
Contamination 3 3
Leak/Splash 2 2
Product Quality Problem 2 2
Unsealed Device Packaging 2 2
Disconnection 2 2
Entrapment of Device 2 2
Biofilm coating in Device 2 2
Collapse 2 2
Component Incompatible 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5171 5171
Pain 4396 4396
Joint Dislocation 2562 2562
Unspecified Infection 2296 2305
Injury 1862 1862
Foreign Body Reaction 1496 1496
Test Result 1289 1289
No Clinical Signs, Symptoms or Conditions 1121 1121
Failure of Implant 1025 1120
No Information 925 925
Insufficient Information 910 910
Inflammation 842 842
Bone Fracture(s) 795 809
Osteolysis 790 790
Tissue Damage 765 765
Inadequate Osseointegration 687 687
Metal Related Pathology 629 629
Ambulation Difficulties 582 582
Reaction 562 562
Hypersensitivity/Allergic reaction 552 552
No Consequences Or Impact To Patient 526 526
Discomfort 514 514
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 482 482
Joint Laxity 439 439
No Known Impact Or Consequence To Patient 395 395
Limited Mobility Of The Implanted Joint 392 392
Loss of Range of Motion 345 345
Fall 285 285
Necrosis 241 241
Edema 225 225
Swelling/ Edema 199 199
No Patient Involvement 189 189
Adhesion(s) 177 177
Unspecified Tissue Injury 175 175
Ossification 153 153
Scar Tissue 140 159
Hematoma 135 135
Synovitis 123 123
Swelling 121 121
Joint Disorder 104 104
Hemorrhage/Bleeding 104 104
Weakness 97 97
Host-Tissue Reaction 93 93
Fatigue 92 92
Hip Fracture 92 92
Osteopenia/ Osteoporosis 92 92
Physical Asymmetry 89 89
Thrombosis 88 88
Pulmonary Embolism 87 87
Cyst(s) 84 84
Local Reaction 84 84
Distress 84 84
Not Applicable 71 71
Wound Dehiscence 70 70
Nerve Damage 67 67
Fever 65 65
Fluid Discharge 63 63
Bacterial Infection 57 57
Anxiety 54 54
Muscular Rigidity 53 53
Death 52 52
Deformity/ Disfigurement 51 51
Impaired Healing 50 58
Muscle/Tendon Damage 49 49
Blood Loss 46 46
Hypoesthesia 44 44
Sepsis 39 39
Erythema 38 38
Unequal Limb Length 37 37
Limb Fracture 36 36
Post Operative Wound Infection 34 34
Pocket Erosion 34 34
Abscess 33 33
Thrombosis/Thrombus 33 33
Erosion 32 32
Depression 30 30
Rash 29 29
Implant Pain 28 28
Myocardial Infarction 26 26
Foreign Body In Patient 25 25
Cardiac Arrest 24 24
Anemia 24 24
Renal Failure 24 24
Toxicity 24 24
Numbness 23 23
Reaction to Medicinal Component of Device 22 22
Headache 22 22
Seroma 21 21
Tinnitus 20 20
Memory Loss/Impairment 20 20
Stroke/CVA 20 20
Low Blood Pressure/ Hypotension 19 19
Unspecified Musculoskeletal problem 18 18
Fibrosis 18 18
Subluxation 17 17
Pneumonia 17 17
Arthralgia 17 17
Arrhythmia 16 16
Infarction, Cerebral 15 15
Calcium Deposits/Calcification 14 14

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 Howmedica Osteonics Corp. II Jan-15-2020
9 MicroPort Orthopedics Inc. II Jun-02-2022
10 Zimmer Biomet, Inc. II Nov-02-2020
11 Zimmer Biomet, Inc. II Aug-09-2019
12 Zimmer, Inc. II Sep-07-2023
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