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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
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
EXCERA 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 BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 4894 4894
2016 3990 3990
2017 6140 6140
2018 6741 6741
2019 7418 7418
2020 3507 3507

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 11433 11433
Adverse Event Without Identified Device or Use Problem 5747 5747
Device Dislodged or Dislocated 4921 4921
Naturally Worn 3176 3176
Appropriate Term/Code Not Available 2944 2944
Corroded 1279 1279
Fracture 1214 1214
Loss of Osseointegration 945 945
Break 915 915
Metal Shedding Debris 798 798
Noise, Audible 587 587
Material Disintegration 510 510
Migration or Expulsion of Device 471 471
Loose or Intermittent Connection 433 433
Unstable 420 420
Material Erosion 387 387
Degraded 385 385
Malposition of Device 384 384
Migration 317 317
Loss of or Failure to Bond 299 299
Device Operates Differently Than Expected 297 297
Osseointegration Problem 293 293
Biocompatibility 255 255
Difficult to Insert 206 206
Loosening of Implant Not Related to Bone-Ingrowth 190 190
Nonstandard Device 190 190
Disassembly 152 152
Mechanical Problem 149 149
Device Slipped 144 144
Material Deformation 142 142
Packaging Problem 136 136
Material Integrity Problem 117 117
Detachment of Device or Device Component 107 107
Inadequacy of Device Shape and/or Size 81 81
Difficult to Remove 76 76
Detachment Of Device Component 69 69
Device Markings/Labelling Problem 67 67
Use of Device Problem 66 66
Positioning Problem 65 65
Tear, Rip or Hole in Device Packaging 65 65
Unintended Movement 64 64
Device Contamination with Chemical or Other Material 62 62
Failure To Adhere Or Bond 62 62
Patient-Device Incompatibility 57 57
Crack 54 54
Difficult To Position 45 45
Fitting Problem 44 44
No Apparent Adverse Event 42 42
Separation Failure 41 41
Compatibility Problem 40 40
Device Contaminated During Manufacture or Shipping 39 39
Device-Device Incompatibility 38 38
Connection Problem 36 36
Material Fragmentation 33 33
Device Packaging Compromised 32 32
Failure to Osseointegrate 31 31
Material Separation 29 29
Material Discolored 29 29
Positioning Failure 27 27
Tip 26 26
Material Twisted/Bent 26 26
Device Inoperable 26 26
Patient Device Interaction Problem 24 24
Screw 24 24
Improper or Incorrect Procedure or Method 23 23
Component Missing 22 22
Deformation Due to Compressive Stress 22 22
Separation Problem 22 22
Cup 21 21
Mechanical Jam 20 20
Device Damaged Prior to Use 20 20
Defective Device 19 19
Scratched Material 17 17
Incomplete or Inadequate Connection 16 16
Defective Component 16 16
Difficult or Delayed Positioning 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Device Damaged by Another Device 15 15
Bent 14 14
Device Difficult to Setup or Prepare 14 14
Delivered as Unsterile Product 14 14
Plug 13 13
Ring 13 13
Thread 11 11
Off-Label Use 10 10
Component or Accessory Incompatibility 9 9
Entrapment of Device 9 9
Misassembled 9 9
Disconnection 8 8
Component Falling 8 8
Misconnection 7 7
Label 7 7
Device Appears to Trigger Rejection 7 7
Contamination /Decontamination Problem 7 7
Microbial Contamination of Device 7 7
Unsealed Device Packaging 7 7
Material Protrusion/Extrusion 7 7
Difficult to Open or Remove Packaging Material 6 6
Heads 6 6
Failure to Align 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10740 10740
No Code Available 9575 9575
No Information 5357 5357
Injury 4088 4088
Unspecified Infection 3707 3707
Joint Dislocation 3356 3356
Discomfort 2923 2923
Inflammation 2521 2521
Foreign Body Reaction 2462 2462
Test Result 2057 2057
Tissue Damage 1818 1818
Host-Tissue Reaction 1640 1640
Reaction 1517 1517
Osteolysis 1463 1463
Limited Mobility Of The Implanted Joint 1295 1295
Bone Fracture(s) 1218 1218
No Known Impact Or Consequence To Patient 1195 1195
Not Applicable 1190 1190
No Consequences Or Impact To Patient 950 950
Ambulation Difficulties 784 784
Inadequate Osseointegration 772 772
Hypersensitivity/Allergic reaction 666 666
Loss of Range of Motion 640 640
Swelling 446 446
Necrosis 445 445
Edema 389 389
Fall 370 370
Failure of Implant 349 349
Joint Disorder 342 342
Weakness 314 314
Distress 259 259
No Patient Involvement 251 251
Hematoma 224 224
Hip Fracture 223 223
Synovitis 216 216
Ossification 210 210
Toxicity 178 178
Cyst(s) 175 175
Death 168 168
Adhesion(s) 160 160
Muscular Rigidity 146 146
Thrombosis 143 143
Deformity/ Disfigurement 138 138
Impaired Healing 129 129
Pulmonary Embolism 124 124
Blood Loss 123 123
Local Reaction 120 120
Scar Tissue 111 111
Wound Dehiscence 111 111
Anxiety 109 109
Fatigue 103 103
Hemorrhage/Bleeding 85 85
Hypoesthesia 83 83
Joint Swelling 82 82
Osteopenia/ Osteoporosis 76 76
Nerve Damage 71 71
Depression 63 63
Device Embedded In Tissue or Plaque 55 55
Fever 55 55
Bacterial Infection 54 54
Fibrosis 54 54
Complaint, Ill-Defined 53 53
Cardiac Arrest 51 51
Irritation 50 50
Rash 50 50
Foreign Body In Patient 50 50
Headache 47 47
Erosion 46 46
Scarring 46 46
Sepsis 45 45
Myocardial Infarction 45 45
Abscess 42 42
Skin Irritation 41 41
Insufficient Information 41 41
Pocket Erosion 36 36
Fluid Discharge 35 35
Numbness 35 35
Infarction, Cerebral 34 34
Neuropathy 32 32
Burning Sensation 32 32
Renal Failure 31 31
Memory Loss/Impairment 30 30
Anemia 29 29
Cancer 27 27
Post Operative Wound Infection 26 26
Arthritis 26 26
Cellulitis 26 26
Calcium Deposits/Calcification 25 25
Hearing Impairment 25 25
Seroma 25 25
Embolism 24 24
Encephalopathy 24 24
Heart Failure 24 24
Patient Problem/Medical Problem 24 24
Nausea 23 23
Muscle Spasm(s) 22 22
Staphylococcus Aureus 22 22
Cognitive Changes 22 22
Sleep Dysfunction 21 21
No Clinical Signs, Symptoms or Conditions 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Oct-09-2020
2 Biomet, Inc. II May-28-2020
3 Biomet, Inc. III Jun-11-2015
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 Stryker Howmedica Osteonics Corp. II Nov-17-2015
12 Stryker Howmedica Osteonics Corp. II Mar-03-2015
13 Zimmer Biomet, Inc. II Nov-02-2020
14 Zimmer Biomet, Inc. II Aug-09-2019
15 Zimmer Biomet, Inc. II Dec-04-2018
16 Zimmer Biomet, Inc. II Aug-14-2018
17 Zimmer Biomet, Inc. II Apr-27-2018
18 Zimmer Biomet, Inc. II Mar-14-2018
19 Zimmer Biomet, Inc. II Mar-14-2018
20 Zimmer Biomet, Inc. II Dec-29-2017
21 Zimmer Biomet, Inc. II Mar-27-2017
22 Zimmer Biomet, Inc. II Feb-22-2016
23 Zimmer Manufacturing B.V. II May-16-2016
24 Zimmer Manufacturing B.V. II Mar-12-2016
25 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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