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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., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
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
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 6744 6744
2019 7417 7417
2020 4034 4034
2021 3208 3208
2022 2062 2062
2023 517 517

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7179 7179
Insufficient Information 4693 4693
Device Dislodged or Dislocated 3594 3594
Naturally Worn 1926 1926
Fracture 972 972
Break 868 868
Appropriate Term/Code Not Available 865 865
Corroded 700 700
Loss of Osseointegration 558 558
Degraded 531 531
Material Erosion 419 419
Migration 366 366
Unstable 353 353
Osseointegration Problem 338 338
Noise, Audible 324 324
Loosening of Implant Not Related to Bone-Ingrowth 320 320
Detachment of Device or Device Component 289 289
Loose or Intermittent Connection 289 289
Biocompatibility 270 270
Loss of or Failure to Bond 222 222
Difficult to Insert 212 212
Material Disintegration 185 185
Packaging Problem 174 174
Migration or Expulsion of Device 163 163
Malposition of Device 158 158
Device Operates Differently Than Expected 150 150
Material Deformation 141 141
Nonstandard Device 139 139
Metal Shedding Debris 104 104
Device Contaminated During Manufacture or Shipping 97 97
Material Twisted/Bent 88 88
Use of Device Problem 88 88
Mechanical Problem 75 75
Unintended Movement 74 74
Connection Problem 72 72
Tear, Rip or Hole in Device Packaging 70 70
Patient Device Interaction Problem 66 66
Difficult to Remove 64 64
Positioning Failure 62 62
Device Markings/Labelling Problem 62 62
Inadequacy of Device Shape and/or Size 49 49
Crack 45 45
Device-Device Incompatibility 42 42
Incomplete or Inadequate Connection 42 42
No Apparent Adverse Event 40 40
Fitting Problem 40 40
Material Fragmentation 38 38
Mechanical Jam 35 35
Off-Label Use 34 34
Failure to Osseointegrate 31 31
Positioning Problem 31 31
Separation Failure 30 30
Defective Device 30 30
Patient-Device Incompatibility 28 28
Disassembly 28 28
Physical Resistance/Sticking 27 27
Device Inoperable 24 24
Device Slipped 23 23
Separation Problem 23 23
Material Integrity Problem 22 22
Device Damaged Prior to Use 20 20
Device Difficult to Setup or Prepare 19 19
Material Discolored 19 19
Delivered as Unsterile Product 17 17
Difficult To Position 17 17
Defective Component 17 17
Device Packaging Compromised 17 17
Difficult or Delayed Positioning 16 16
Premature Separation 16 16
Deformation Due to Compressive Stress 15 15
Device Damaged by Another Device 14 14
Device Contamination with Chemical or Other Material 14 14
Scratched Material 14 14
Device Appears to Trigger Rejection 14 14
Manufacturing, Packaging or Shipping Problem 12 12
Dull, Blunt 11 11
Improper or Incorrect Procedure or Method 11 11
Component Missing 11 11
Material Separation 10 10
Flaked 9 9
Inaccurate Information 9 9
Difficult or Delayed Separation 8 8
Illegible Information 7 7
Disconnection 7 7
Peeled/Delaminated 7 7
Contamination /Decontamination Problem 7 7
Failure to Advance 6 6
Unsealed Device Packaging 6 6
Detachment Of Device Component 6 6
Misassembled 6 6
Failure To Adhere Or Bond 5 5
Expiration Date Error 5 5
Activation, Positioning or Separation Problem 5 5
Difficult to Open or Remove Packaging Material 4 4
Compatibility Problem 4 4
Collapse 4 4
Misconnection 4 4
Entrapment of Device 4 4
Microbial Contamination of Device 4 4
Particulates 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6496 6496
No Code Available 6368 6368
Joint Dislocation 3253 3253
Injury 3151 3151
Unspecified Infection 2858 2858
Test Result 1921 1921
Foreign Body Reaction 1678 1678
No Information 1572 1572
Inflammation 1554 1554
Tissue Damage 1306 1306
Discomfort 1160 1160
No Clinical Signs, Symptoms or Conditions 1069 1069
Reaction 1054 1054
Not Applicable 1028 1028
Osteolysis 999 999
Bone Fracture(s) 942 942
Failure of Implant 846 846
Inadequate Osseointegration 842 842
No Known Impact Or Consequence To Patient 775 775
No Consequences Or Impact To Patient 756 756
Ambulation Difficulties 746 746
Limited Mobility Of The Implanted Joint 713 713
Insufficient Information 689 689
Hypersensitivity/Allergic reaction 664 664
Metal Related Pathology 587 587
Loss of Range of Motion 569 569
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 529 529
Host-Tissue Reaction 395 395
Joint Laxity 372 372
Necrosis 353 353
Fall 335 335
Distress 325 325
Edema 282 282
Swelling 255 255
No Patient Involvement 245 245
Adhesion(s) 217 217
Weakness 216 216
Joint Disorder 212 212
Unspecified Tissue Injury 205 205
Hematoma 202 202
Swelling/ Edema 193 193
Ossification 193 193
Scar Tissue 189 189
Synovitis 165 165
Impaired Healing 139 139
Hip Fracture 133 133
Deformity/ Disfigurement 132 132
Wound Dehiscence 131 131
Fatigue 122 122
Cyst(s) 116 116
Thrombosis 113 113
Hemorrhage/Bleeding 113 113
Local Reaction 113 113
Pulmonary Embolism 112 112
Blood Loss 103 103
Anxiety 101 101
Osteopenia/ Osteoporosis 99 99
Bacterial Infection 95 95
Physical Asymmetry 91 91
Death 81 81
Muscular Rigidity 76 76
Nerve Damage 70 70
Fever 69 69
Fluid Discharge 60 60
Hypoesthesia 59 59
Depression 53 53
Sepsis 49 49
Fibrosis 47 47
Post Operative Wound Infection 43 43
Muscle/Tendon Damage 43 43
Abscess 43 43
Myocardial Infarction 42 42
Pocket Erosion 41 41
Rash 40 40
Numbness 40 40
Erosion 39 39
Cardiac Arrest 38 38
Headache 37 37
Erythema 37 37
Foreign Body In Patient 36 36
Limb Fracture 33 33
Thrombosis/Thrombus 31 31
Toxicity 31 31
Renal Failure 31 31
Anemia 30 30
Memory Loss/Impairment 28 28
Scarring 27 27
Unequal Limb Length 26 26
Infarction, Cerebral 26 26
Seroma 24 24
Tinnitus 24 24
Neuropathy 23 23
Reaction to Medicinal Component of Device 22 22
Stroke/CVA 22 22
Cellulitis 21 21
Calcium Deposits/Calcification 20 20
Device Embedded In Tissue or Plaque 20 20
Low Blood Pressure/ Hypotension 20 20
Pneumonia 19 19
Hearing Impairment 19 19

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 Howmedica Osteonics Corp. II Oct-11-2018
10 MicroPort Orthopedics Inc. II Jun-02-2022
11 Smith & Nephew, Inc. II May-09-2018
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
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