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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
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
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
2016 3991 3991
2017 6140 6140
2018 6741 6741
2019 7416 7416
2020 4030 4030
2021 501 501

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 9112 9112
Adverse Event Without Identified Device or Use Problem 5682 5682
Device Dislodged or Dislocated 4300 4300
Naturally Worn 2414 2414
Appropriate Term/Code Not Available 2234 2234
Fracture 1082 1082
Corroded 1044 1044
Break 839 839
Loss of Osseointegration 806 806
Metal Shedding Debris 569 569
Noise, Audible 426 426
Migration or Expulsion of Device 422 422
Material Erosion 403 403
Unstable 387 387
Material Disintegration 378 378
Degraded 371 371
Loose or Intermittent Connection 340 340
Migration 316 316
Malposition of Device 296 296
Osseointegration Problem 289 289
Loss of or Failure to Bond 258 258
Biocompatibility 256 256
Difficult to Insert 216 216
Device Operates Differently Than Expected 208 208
Loosening of Implant Not Related to Bone-Ingrowth 201 201
Nonstandard Device 187 187
Material Deformation 138 138
Packaging Problem 130 130
Mechanical Problem 124 124
Detachment of Device or Device Component 117 117
Disassembly 110 110
Difficult to Remove 70 70
Use of Device Problem 68 68
Device Markings/Labelling Problem 64 64
Unintended Movement 64 64
Tear, Rip or Hole in Device Packaging 60 60
Inadequacy of Device Shape and/or Size 60 60
Material Integrity Problem 59 59
Positioning Problem 54 54
Device Contamination with Chemical or Other Material 51 51
Device Slipped 51 51
Difficult To Position 44 44
Crack 44 44
Device Contaminated During Manufacture or Shipping 44 44
Device-Device Incompatibility 43 43
Fitting Problem 43 43
Separation Failure 43 43
Connection Problem 42 42
Detachment Of Device Component 42 42
Failure To Adhere Or Bond 39 39
No Apparent Adverse Event 37 37
Positioning Failure 36 36
Patient-Device Incompatibility 33 33
Failure to Osseointegrate 30 30
Patient Device Interaction Problem 29 29
Material Twisted/Bent 29 29
Device Packaging Compromised 27 27
Material Fragmentation 27 27
Device Inoperable 24 24
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Device Damaged Prior to Use 21 21
Material Discolored 21 21
Component Missing 20 20
Mechanical Jam 20 20
Defective Device 19 19
Material Separation 19 19
Incomplete or Inadequate Connection 19 19
Compatibility Problem 17 17
Scratched Material 17 17
Defective Component 17 17
Improper or Incorrect Procedure or Method 16 16
Difficult or Delayed Positioning 16 16
Device Damaged by Another Device 16 16
Device Difficult to Setup or Prepare 15 15
Off-Label Use 14 14
Delivered as Unsterile Product 14 14
Cup 13 13
Tip 13 13
Bent 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Entrapment of Device 9 9
Premature Separation 9 9
Screw 9 9
Component or Accessory Incompatibility 8 8
Misassembled 8 8
Disconnection 8 8
Device Appears to Trigger Rejection 7 7
Contamination /Decontamination Problem 7 7
Physical Resistance/Sticking 7 7
Microbial Contamination of Device 7 7
Unsealed Device Packaging 7 7
Difficult or Delayed Separation 7 7
Thread 6 6
Misconnection 6 6
Flaked 6 6
Peeled/Delaminated 5 5
Contamination 5 5
Plug 5 5
Device Disinfection Or Sterilization Issue 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8635 8635
No Code Available 7897 7897
No Information 4369 4369
Injury 3934 3934
Joint Dislocation 3339 3339
Unspecified Infection 3297 3297
Foreign Body Reaction 2024 2024
Test Result 1988 1988
Discomfort 1959 1959
Inflammation 1897 1897
Tissue Damage 1660 1660
Reaction 1470 1470
Osteolysis 1255 1255
Not Applicable 1151 1151
Limited Mobility Of The Implanted Joint 1137 1137
Bone Fracture(s) 1135 1135
Host-Tissue Reaction 1094 1094
No Known Impact Or Consequence To Patient 1066 1066
No Consequences Or Impact To Patient 935 935
Inadequate Osseointegration 786 786
Ambulation Difficulties 700 700
Hypersensitivity/Allergic reaction 617 617
Loss of Range of Motion 572 572
Necrosis 389 389
Failure of Implant 384 384
Swelling 367 367
Edema 349 349
Joint Disorder 334 334
Fall 316 316
Weakness 284 284
No Patient Involvement 258 258
Distress 257 257
Hip Fracture 219 219
Hematoma 214 214
Ossification 187 187
Synovitis 186 186
Adhesion(s) 157 157
Death 157 157
Insufficient Information 149 149
Cyst(s) 147 147
Thrombosis 139 139
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 139 139
Deformity/ Disfigurement 131 131
No Clinical Signs, Symptoms or Conditions 128 128
Muscular Rigidity 126 126
Impaired Healing 123 123
Blood Loss 120 120
Local Reaction 119 119
Wound Dehiscence 115 115
Pulmonary Embolism 114 114
Anxiety 107 107
Fatigue 102 102
Scar Tissue 100 100
Hemorrhage/Bleeding 82 82
Toxicity 81 81
Osteopenia/ Osteoporosis 75 75
Hypoesthesia 71 71
Nerve Damage 66 66
Bacterial Infection 61 61
Depression 61 61
Fibrosis 51 51
Fever 51 51
Joint Swelling 50 50
Headache 46 46
Cardiac Arrest 45 45
Myocardial Infarction 45 45
Foreign Body In Patient 45 45
Device Embedded In Tissue or Plaque 44 44
Sepsis 44 44
Erosion 41 41
Abscess 41 41
Irritation 39 39
Scarring 39 39
Pocket Erosion 35 35
Joint Laxity 35 35
Rash 35 35
Skin Irritation 33 33
Infarction, Cerebral 32 32
Renal Failure 31 31
Neuropathy 31 31
Metal Related Pathology 31 31
Numbness 30 30
Memory Loss/Impairment 30 30
Post Operative Wound Infection 30 30
Anemia 29 29
Complaint, Ill-Defined 26 26
Cellulitis 26 26
Embolism 24 24
Heart Failure 24 24
Burning Sensation 24 24
Patient Problem/Medical Problem 24 24
Encephalopathy 24 24
Fluid Discharge 24 24
Arthritis 23 23
Calcium Deposits/Calcification 23 23
Seroma 23 23
Cognitive Changes 22 22
Reaction to Medicinal Component of Device 22 22
Swelling/ Edema 21 21
Nausea 20 20

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 Exactech, Inc. II Jan-17-2017
5 Howmedica Osteonics Corp. II Jan-15-2020
6 Howmedica Osteonics Corp. II Oct-11-2018
7 Smith & Nephew, Inc. II May-09-2018
8 Smith & Nephew, Inc. II Jan-11-2017
9 Stryker Howmedica Osteonics Corp. II Nov-09-2016
10 Stryker Howmedica Osteonics Corp. II Aug-11-2016
11 Zimmer Biomet, Inc. II Nov-02-2020
12 Zimmer Biomet, Inc. II Aug-09-2019
13 Zimmer Biomet, Inc. II Dec-04-2018
14 Zimmer Biomet, Inc. II Aug-14-2018
15 Zimmer Biomet, Inc. II Apr-27-2018
16 Zimmer Biomet, Inc. II Mar-14-2018
17 Zimmer Biomet, Inc. II Mar-14-2018
18 Zimmer Biomet, Inc. II Dec-29-2017
19 Zimmer Biomet, Inc. II Mar-27-2017
20 Zimmer Biomet, Inc. II Feb-22-2016
21 Zimmer Manufacturing B.V. II May-16-2016
22 Zimmer Manufacturing B.V. II Mar-12-2016
23 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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