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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 1
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
SURGTECH, INC.,
  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
2017 6144 6144
2018 6738 6738
2019 7414 7414
2020 4032 4032
2021 3200 3200
2022 1264 1264

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7586 7586
Adverse Event Without Identified Device or Use Problem 7004 7004
Device Dislodged or Dislocated 4258 4258
Naturally Worn 2188 2188
Appropriate Term/Code Not Available 1572 1572
Fracture 1127 1127
Break 964 964
Corroded 952 952
Loss of Osseointegration 685 685
Degraded 491 491
Material Erosion 435 435
Unstable 409 409
Metal Shedding Debris 395 395
Noise, Audible 390 390
Migration 349 349
Loose or Intermittent Connection 342 342
Migration or Expulsion of Device 333 333
Osseointegration Problem 326 326
Loosening of Implant Not Related to Bone-Ingrowth 297 297
Material Disintegration 292 292
Biocompatibility 267 267
Difficult to Insert 259 259
Loss of or Failure to Bond 247 247
Detachment of Device or Device Component 239 239
Malposition of Device 229 229
Material Deformation 191 191
Device Operates Differently Than Expected 186 186
Packaging Problem 174 174
Nonstandard Device 163 163
Mechanical Problem 115 115
Device Contaminated During Manufacture or Shipping 95 95
Material Twisted/Bent 88 88
Use of Device Problem 84 84
Unintended Movement 74 74
Connection Problem 74 74
Tear, Rip or Hole in Device Packaging 72 72
Difficult to Remove 70 70
Device Markings/Labelling Problem 63 63
Disassembly 62 62
Patient Device Interaction Problem 58 58
Positioning Failure 57 57
Inadequacy of Device Shape and/or Size 56 56
Crack 53 53
Fitting Problem 50 50
Device-Device Incompatibility 48 48
Positioning Problem 47 47
Material Fragmentation 43 43
Incomplete or Inadequate Connection 42 42
No Apparent Adverse Event 39 39
Material Integrity Problem 38 38
Separation Failure 38 38
Difficult To Position 38 38
Mechanical Jam 37 37
Device Slipped 34 34
Failure to Osseointegrate 33 33
Patient-Device Incompatibility 33 33
Defective Device 32 32
Off-Label Use 29 29
Physical Resistance/Sticking 27 27
Device Packaging Compromised 25 25
Device Inoperable 24 24
Device Contamination with Chemical or Other Material 23 23
Material Discolored 23 23
Separation Problem 22 22
Detachment Of Device Component 21 21
Deformation Due to Compressive Stress 21 21
Device Damaged Prior to Use 20 20
Device Difficult to Setup or Prepare 19 19
Component Missing 18 18
Scratched Material 18 18
Delivered as Unsterile Product 17 17
Improper or Incorrect Procedure or Method 17 17
Failure To Adhere Or Bond 17 17
Difficult or Delayed Positioning 16 16
Premature Separation 16 16
Defective Component 15 15
Device Damaged by Another Device 15 15
Manufacturing, Packaging or Shipping Problem 14 14
Material Separation 14 14
Dull, Blunt 12 12
Bent 11 11
Compatibility Problem 10 10
Flaked 9 9
Entrapment of Device 8 8
Misassembled 8 8
Unsealed Device Packaging 8 8
Device Appears to Trigger Rejection 8 8
Difficult or Delayed Separation 8 8
Inaccurate Information 7 7
Microbial Contamination of Device 7 7
Disconnection 7 7
Contamination /Decontamination Problem 7 7
Difficult to Open or Remove Packaging Material 6 6
Peeled/Delaminated 6 6
Contamination 5 5
Material Protrusion/Extrusion 5 5
Activation, Positioning or SeparationProblem 5 5
Device Disinfection Or Sterilization Issue 5 5
Failure to Align 5 5
Illegible Information 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7966 7966
No Code Available 7145 7145
Joint Dislocation 3708 3708
Injury 3698 3698
Unspecified Infection 3322 3322
No Information 3170 3170
Test Result 1944 1944
Foreign Body Reaction 1902 1902
Inflammation 1805 1805
Discomfort 1533 1533
Tissue Damage 1512 1512
Reaction 1362 1362
Osteolysis 1152 1152
Bone Fracture(s) 1107 1107
Not Applicable 1106 1106
No Known Impact Or Consequence To Patient 980 980
No Clinical Signs, Symptoms or Conditions 972 972
Limited Mobility Of The Implanted Joint 928 928
Inadequate Osseointegration 871 871
No Consequences Or Impact To Patient 865 865
Ambulation Difficulties 856 856
Failure of Implant 740 740
Host-Tissue Reaction 737 737
Hypersensitivity/Allergic reaction 664 664
Loss of Range of Motion 621 621
Insufficient Information 552 552
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 500 500
Necrosis 398 398
Fall 367 367
Metal Related Pathology 350 350
Swelling 328 328
Edema 319 319
Joint Disorder 311 311
Distress 309 309
Weakness 265 265
Joint Laxity 257 257
No Patient Involvement 254 254
Hematoma 230 230
Hip Fracture 214 214
Ossification 210 210
Adhesion(s) 183 183
Synovitis 180 180
Scar Tissue 156 156
Impaired Healing 142 142
Cyst(s) 140 140
Wound Dehiscence 139 139
Deformity/ Disfigurement 139 139
Death 138 138
Thrombosis 135 135
Fatigue 125 125
Local Reaction 123 123
Pulmonary Embolism 121 121
Unspecified Tissue Injury 121 121
Swelling/ Edema 120 120
Blood Loss 110 110
Hemorrhage/Bleeding 107 107
Muscular Rigidity 106 106
Anxiety 105 105
Osteopenia/ Osteoporosis 91 91
Bacterial Infection 91 91
Nerve Damage 79 79
Fever 77 77
Hypoesthesia 67 67
Fluid Discharge 64 64
Sepsis 62 62
Depression 56 56
Physical Asymmetry 55 55
Myocardial Infarction 51 51
Fibrosis 48 48
Post Operative Wound Infection 46 46
Abscess 46 46
Foreign Body In Patient 45 45
Erosion 44 44
Headache 43 43
Rash 43 43
Numbness 43 43
Toxicity 42 42
Cardiac Arrest 42 42
Device Embedded In Tissue or Plaque 38 38
Scarring 37 37
Pocket Erosion 37 37
Erythema 36 36
Renal Failure 35 35
Muscle/Tendon Damage 33 33
Anemia 32 32
Neuropathy 31 31
Memory Loss/Impairment 30 30
Infarction, Cerebral 30 30
Irritation 29 29
Seroma 26 26
Cellulitis 26 26
Encephalopathy 24 24
Calcium Deposits/Calcification 23 23
Arthritis 23 23
Skin Irritation 23 23
Patient Problem/Medical Problem 23 23
Joint Swelling 23 23
Complaint, Ill-Defined 23 23
Heart Failure 23 23
Unequal Limb Length 22 22

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-09-2022
5 DePuy Orthopaedics, Inc. II Jun-10-2021
6 Exactech, Inc. II Jan-17-2017
7 Howmedica Osteonics Corp. II Jan-15-2020
8 Howmedica Osteonics Corp. II Oct-11-2018
9 MicroPort Orthopedics Inc. II Jun-02-2022
10 Smith & Nephew, Inc. II May-09-2018
11 Smith & Nephew, Inc. II Jan-11-2017
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
19 Zimmer Biomet, Inc. II Dec-29-2017
20 Zimmer Biomet, Inc. II Mar-27-2017
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