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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 7405 7405
2020 4015 4015
2021 3171 3171
2022 1980 1980
2023 1653 1798
2024 362 362

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6730 6780
Device Dislodged or Dislocated 2887 2887
Insufficient Information 2198 2278
Naturally Worn 1569 1569
Fracture 798 818
Break 732 732
Corroded 540 540
Degraded 534 534
Loss of Osseointegration 450 450
Material Erosion 387 387
Loosening of Implant Not Related to Bone-Ingrowth 365 368
Detachment of Device or Device Component 338 342
Migration 336 342
Appropriate Term/Code Not Available 326 326
Osseointegration Problem 304 304
Unstable 299 299
Noise, Audible 213 213
Loss of or Failure to Bond 199 199
Biocompatibility 189 189
Difficult to Insert 176 176
Loose or Intermittent Connection 137 137
Packaging Problem 122 122
Nonstandard Device 120 120
Malposition of Device 111 111
Use of Device Problem 105 105
Material Deformation 96 96
Material Twisted/Bent 91 91
Device Contaminated During Manufacture or Shipping 88 88
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 43 43
Incomplete or Inadequate Connection 42 42
Migration or Expulsion of Device 38 42
Inadequacy of Device Shape and/or Size 37 37
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
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
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 4450 4450
Joint Dislocation 2589 2589
Unspecified Infection 2326 2335
Injury 1862 1862
Foreign Body Reaction 1518 1518
Test Result 1289 1289
No Clinical Signs, Symptoms or Conditions 1140 1140
Failure of Implant 1082 1177
Insufficient Information 948 948
No Information 925 925
Inflammation 843 843
Osteolysis 810 810
Bone Fracture(s) 805 819
Tissue Damage 765 765
Inadequate Osseointegration 694 694
Metal Related Pathology 653 653
Ambulation Difficulties 585 585
Reaction 562 562
Hypersensitivity/Allergic reaction 556 556
No Consequences Or Impact To Patient 526 526
Discomfort 515 515
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 483 483
Joint Laxity 459 459
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 290 290
Necrosis 241 241
Edema 225 225
Swelling/ Edema 206 206
No Patient Involvement 189 189
Adhesion(s) 177 177
Unspecified Tissue Injury 176 176
Ossification 154 154
Scar Tissue 140 159
Hematoma 139 139
Synovitis 130 130
Swelling 121 121
Hemorrhage/Bleeding 106 106
Joint Disorder 104 104
Weakness 97 97
Hip Fracture 93 93
Fatigue 93 93
Host-Tissue Reaction 93 93
Osteopenia/ Osteoporosis 93 93
Physical Asymmetry 91 91
Thrombosis 88 88
Pulmonary Embolism 87 87
Cyst(s) 85 85
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 57 57
Muscular Rigidity 56 56
Anxiety 54 54
Deformity/ Disfigurement 52 52
Death 52 52
Muscle/Tendon Damage 51 51
Impaired Healing 50 58
Blood Loss 46 46
Hypoesthesia 44 44
Unequal Limb Length 41 41
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
Rash 29 29
Implant Pain 29 29
Foreign Body In Patient 26 26
Myocardial Infarction 26 26
Anemia 26 26
Cardiac Arrest 24 24
Renal Failure 24 24
Toxicity 24 24
Numbness 23 23
Reaction to Medicinal Component of Device 22 22
Headache 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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