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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
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 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 7406 7406
2020 4015 4015
2021 3171 3171
2022 1980 1980
2023 1653 1798
2024 517 517

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6783 6833
Device Dislodged or Dislocated 2908 2908
Insufficient Information 2210 2290
Naturally Worn 1630 1630
Fracture 806 826
Break 735 735
Corroded 547 547
Degraded 544 544
Loss of Osseointegration 452 452
Material Erosion 389 389
Loosening of Implant Not Related to Bone-Ingrowth 369 372
Detachment of Device or Device Component 344 348
Migration 336 342
Appropriate Term/Code Not Available 326 326
Osseointegration Problem 309 309
Unstable 300 300
Noise, Audible 213 213
Loss of or Failure to Bond 200 200
Biocompatibility 189 189
Difficult to Insert 179 179
Loose or Intermittent Connection 137 137
Packaging Problem 122 122
Nonstandard Device 120 120
Malposition of Device 111 111
Use of Device Problem 107 107
Material Deformation 99 99
Material Twisted/Bent 91 91
Device Contaminated During Manufacture or Shipping 89 89
Patient Device Interaction Problem 78 78
Unintended Movement 72 72
Connection Problem 67 67
Positioning Failure 67 67
Tear, Rip or Hole in Device Packaging 64 64
Device Markings/Labelling Problem 58 58
Material Disintegration 53 53
Mechanical Problem 46 48
Difficult to Remove 44 44
Incomplete or Inadequate Connection 42 42
Inadequacy of Device Shape and/or Size 38 38
Migration or Expulsion of Device 38 42
No Apparent Adverse Event 36 36
Off-Label Use 35 35
Material Fragmentation 34 34
Crack 34 34
Fitting Problem 33 33
Mechanical Jam 32 32
Defective Device 31 31
Device-Device Incompatibility 30 30
Failure to Osseointegrate 28 28
Physical Resistance/Sticking 27 27
Positioning Problem 24 24
Patient-Device Incompatibility 20 20
Separation Failure 19 19
Device Appears to Trigger Rejection 19 19
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 16 16
Device Damaged Prior to Use 15 15
Manufacturing, Packaging or Shipping Problem 14 14
Difficult or Delayed Positioning 13 13
Improper or Incorrect Procedure or Method 12 12
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
Difficult to Open or Remove Packaging Material 4 4
Compatibility Problem 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
Unsealed Device Packaging 3 3
Contamination 3 3
Leak/Splash 2 2
Product Quality Problem 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 4491 4491
Joint Dislocation 2608 2608
Unspecified Infection 2340 2349
Injury 1863 1863
Foreign Body Reaction 1530 1530
Test Result 1289 1289
Failure of Implant 1164 1259
No Clinical Signs, Symptoms or Conditions 1150 1150
Insufficient Information 963 963
No Information 925 925
Inflammation 844 844
Bone Fracture(s) 822 836
Osteolysis 816 816
Tissue Damage 765 765
Inadequate Osseointegration 702 702
Metal Related Pathology 671 671
Ambulation Difficulties 592 592
Reaction 562 562
Hypersensitivity/Allergic reaction 559 559
No Consequences Or Impact To Patient 526 526
Discomfort 517 517
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 483 483
Joint Laxity 468 468
No Known Impact Or Consequence To Patient 395 395
Limited Mobility Of The Implanted Joint 392 392
Loss of Range of Motion 349 349
Fall 294 294
Necrosis 243 243
Edema 225 225
Swelling/ Edema 210 210
No Patient Involvement 189 189
Adhesion(s) 178 178
Unspecified Tissue Injury 176 176
Ossification 156 156
Scar Tissue 141 160
Hematoma 140 140
Synovitis 131 131
Swelling 121 121
Hemorrhage/Bleeding 106 106
Joint Disorder 104 104
Osteopenia/ Osteoporosis 97 97
Weakness 97 97
Fatigue 95 95
Host-Tissue Reaction 93 93
Hip Fracture 93 93
Physical Asymmetry 91 91
Thrombosis 88 88
Pulmonary Embolism 87 87
Cyst(s) 87 87
Distress 85 85
Local Reaction 84 84
Not Applicable 71 71
Wound Dehiscence 70 70
Nerve Damage 68 68
Fever 65 65
Fluid Discharge 64 64
Bacterial Infection 59 59
Muscular Rigidity 56 56
Anxiety 54 54
Muscle/Tendon Damage 53 53
Deformity/ Disfigurement 52 52
Death 52 52
Impaired Healing 50 58
Blood Loss 46 46
Hypoesthesia 44 44
Unequal Limb Length 42 42
Sepsis 40 40
Erythema 38 38
Limb Fracture 36 36
Thrombosis/Thrombus 35 35
Post Operative Wound Infection 35 35
Pocket Erosion 34 34
Abscess 33 33
Erosion 32 32
Depression 30 30
Implant Pain 30 30
Rash 29 29
Myocardial Infarction 26 26
Anemia 26 26
Foreign Body In Patient 26 26
Numbness 25 25
Toxicity 24 24
Cardiac Arrest 24 24
Renal Failure 24 24
Headache 22 22
Reaction to Medicinal Component of Device 22 22
Memory Loss/Impairment 21 21
Seroma 21 21
Tinnitus 21 21
Stroke/CVA 20 20
Low Blood Pressure/ Hypotension 19 19
Unspecified Musculoskeletal problem 18 18
Fibrosis 18 18
Subluxation 17 17
Arthralgia 17 17
Pneumonia 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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