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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 6739 6739
2019 7415 7415
2020 4033 4033
2021 3204 3204
2022 1790 1790

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7608 7608
Adverse Event Without Identified Device or Use Problem 7244 7244
Device Dislodged or Dislocated 4355 4355
Naturally Worn 2260 2260
Appropriate Term/Code Not Available 1576 1576
Fracture 1147 1147
Break 968 968
Corroded 966 966
Loss of Osseointegration 690 690
Degraded 512 512
Material Erosion 459 459
Unstable 423 423
Noise, Audible 396 396
Metal Shedding Debris 395 395
Migration 356 356
Loose or Intermittent Connection 344 344
Osseointegration Problem 338 338
Migration or Expulsion of Device 334 334
Loosening of Implant Not Related to Bone-Ingrowth 303 303
Material Disintegration 292 292
Biocompatibility 268 268
Difficult to Insert 264 264
Detachment of Device or Device Component 260 260
Loss of or Failure to Bond 250 250
Malposition of Device 231 231
Material Deformation 191 191
Device Operates Differently Than Expected 186 186
Packaging Problem 182 182
Nonstandard Device 165 165
Mechanical Problem 118 118
Device Contaminated During Manufacture or Shipping 97 97
Material Twisted/Bent 89 89
Use of Device Problem 87 87
Unintended Movement 76 76
Difficult to Remove 74 74
Connection Problem 74 74
Tear, Rip or Hole in Device Packaging 73 73
Device Markings/Labelling Problem 63 63
Disassembly 62 62
Patient Device Interaction Problem 62 62
Positioning Failure 60 60
Inadequacy of Device Shape and/or Size 57 57
Crack 53 53
Fitting Problem 50 50
Device-Device Incompatibility 49 49
Positioning Problem 47 47
Material Fragmentation 43 43
Incomplete or Inadequate Connection 42 42
No Apparent Adverse Event 40 40
Difficult To Position 38 38
Material Integrity Problem 38 38
Separation Failure 38 38
Mechanical Jam 37 37
Failure to Osseointegrate 35 35
Device Slipped 34 34
Off-Label Use 33 33
Patient-Device Incompatibility 33 33
Defective Device 32 32
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
Defective Component 16 16
Premature Separation 16 16
Device Damaged by Another Device 15 15
Manufacturing, Packaging or Shipping Problem 14 14
Material Separation 14 14
Dull, Blunt 12 12
Device Appears to Trigger Rejection 11 11
Bent 11 11
Compatibility Problem 10 10
Flaked 9 9
Inaccurate Information 9 9
Difficult or Delayed Separation 8 8
Entrapment of Device 8 8
Misassembled 8 8
Unsealed Device Packaging 8 8
Peeled/Delaminated 7 7
Microbial Contamination of Device 7 7
Disconnection 7 7
Contamination /Decontamination Problem 7 7
Failure to Advance 6 6
Difficult to Open or Remove Packaging Material 6 6
Illegible Information 6 6
Device Disinfection Or Sterilization Issue 5 5
Material Protrusion/Extrusion 5 5
Expiration Date Error 5 5
Failure to Align 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8074 8074
No Code Available 7148 7148
Joint Dislocation 3804 3804
Injury 3698 3698
Unspecified Infection 3393 3393
No Information 3170 3170
Foreign Body Reaction 1973 1973
Test Result 1945 1945
Inflammation 1820 1820
Discomfort 1557 1557
Tissue Damage 1512 1512
Reaction 1362 1362
Osteolysis 1176 1176
Bone Fracture(s) 1121 1121
Not Applicable 1107 1107
No Clinical Signs, Symptoms or Conditions 1012 1012
No Known Impact Or Consequence To Patient 980 980
Limited Mobility Of The Implanted Joint 928 928
Ambulation Difficulties 894 894
Inadequate Osseointegration 887 887
No Consequences Or Impact To Patient 865 865
Failure of Implant 808 808
Host-Tissue Reaction 737 737
Hypersensitivity/Allergic reaction 688 688
Loss of Range of Motion 643 643
Insufficient Information 594 594
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 513 513
Metal Related Pathology 447 447
Necrosis 403 403
Fall 383 383
Swelling 328 328
Distress 320 320
Edema 319 319
Joint Disorder 311 311
Joint Laxity 311 311
Weakness 265 265
No Patient Involvement 254 254
Hematoma 233 233
Ossification 215 215
Hip Fracture 214 214
Synovitis 191 191
Adhesion(s) 188 188
Scar Tissue 164 164
Unspecified Tissue Injury 154 154
Swelling/ Edema 148 148
Impaired Healing 144 144
Cyst(s) 144 144
Wound Dehiscence 141 141
Deformity/ Disfigurement 141 141
Death 138 138
Fatigue 136 136
Thrombosis 135 135
Local Reaction 124 124
Pulmonary Embolism 123 123
Hemorrhage/Bleeding 114 114
Muscular Rigidity 114 114
Blood Loss 110 110
Anxiety 109 109
Osteopenia/ Osteoporosis 97 97
Bacterial Infection 94 94
Nerve Damage 83 83
Fever 77 77
Physical Asymmetry 69 69
Hypoesthesia 67 67
Fluid Discharge 66 66
Sepsis 63 63
Depression 56 56
Myocardial Infarction 51 51
Fibrosis 50 50
Post Operative Wound Infection 48 48
Abscess 47 47
Foreign Body In Patient 46 46
Numbness 45 45
Erosion 44 44
Cardiac Arrest 43 43
Headache 43 43
Rash 43 43
Toxicity 42 42
Device Embedded In Tissue or Plaque 38 38
Pocket Erosion 38 38
Scarring 37 37
Erythema 37 37
Anemia 36 36
Renal Failure 35 35
Muscle/Tendon Damage 33 33
Neuropathy 32 32
Memory Loss/Impairment 30 30
Infarction, Cerebral 30 30
Irritation 29 29
Cellulitis 27 27
Thrombosis/Thrombus 27 27
Seroma 26 26
Tinnitus 25 25
Calcium Deposits/Calcification 24 24
Encephalopathy 24 24
Unequal Limb Length 24 24
Limb Fracture 24 24
Patient Problem/Medical Problem 23 23
Complaint, Ill-Defined 23 23
Joint Swelling 23 23

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 Exactech, Inc. II Jan-17-2017
9 Howmedica Osteonics Corp. II Jan-15-2020
10 Howmedica Osteonics Corp. II Oct-11-2018
11 MicroPort Orthopedics Inc. II Jun-02-2022
12 Smith & Nephew, Inc. II May-09-2018
13 Smith & Nephew, Inc. II Jan-11-2017
14 Zimmer Biomet, Inc. II Nov-02-2020
15 Zimmer Biomet, Inc. II Aug-09-2019
16 Zimmer Biomet, Inc. II Dec-04-2018
17 Zimmer Biomet, Inc. II Aug-14-2018
18 Zimmer Biomet, Inc. II Apr-27-2018
19 Zimmer Biomet, Inc. II Mar-14-2018
20 Zimmer Biomet, Inc. II Mar-14-2018
21 Zimmer Biomet, Inc. II Dec-29-2017
22 Zimmer Biomet, Inc. II Mar-27-2017
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