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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 AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  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
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 6138 6138
2018 6736 6736
2019 7406 7406
2020 4015 4015
2021 3171 3171
2022 1980 1980
2023 1653 1798
2024 758 758

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8223 8273
Insufficient Information 7836 7916
Device Dislodged or Dislocated 4703 4703
Naturally Worn 2694 2694
Appropriate Term/Code Not Available 1573 1573
Fracture 1253 1273
Corroded 1009 1009
Break 993 993
Loss of Osseointegration 699 699
Degraded 647 647
Material Erosion 529 529
Unstable 463 463
Noise, Audible 416 416
Loosening of Implant Not Related to Bone-Ingrowth 406 409
Osseointegration Problem 395 395
Metal Shedding Debris 394 394
Migration 386 392
Detachment of Device or Device Component 373 377
Migration or Expulsion of Device 345 349
Loose or Intermittent Connection 345 345
Difficult to Insert 310 310
Material Disintegration 291 291
Biocompatibility 274 274
Loss of or Failure to Bond 266 266
Malposition of Device 239 239
Material Deformation 196 196
Packaging Problem 187 187
Device Operates Differently Than Expected 186 186
Nonstandard Device 165 165
Mechanical Problem 123 125
Use of Device Problem 117 117
Device Contaminated During Manufacture or Shipping 102 102
Material Twisted/Bent 96 96
Patient Device Interaction Problem 86 86
Difficult to Remove 81 81
Tear, Rip or Hole in Device Packaging 79 79
Unintended Movement 78 78
Connection Problem 74 74
Positioning Failure 68 68
Device Markings/Labelling Problem 63 63
Disassembly 62 62
Inadequacy of Device Shape and/or Size 62 62
Crack 55 55
Device-Device Incompatibility 52 52
Fitting Problem 50 50
Positioning Problem 47 47
Failure to Osseointegrate 46 46
Material Fragmentation 45 45
No Apparent Adverse Event 45 45
Incomplete or Inadequate Connection 42 42
Separation Failure 41 41
Material Integrity Problem 40 40
Mechanical Jam 38 38
Difficult To Position 38 38
Off-Label Use 36 36
Patient-Device Incompatibility 35 35
Device Slipped 34 34
Defective Device 33 33
Physical Resistance/Sticking 30 30
Device Appears to Trigger Rejection 27 27
Device Packaging Compromised 25 25
Device Inoperable 24 24
Material Discolored 23 23
Device Contamination with Chemical or Other Material 22 22
Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Detachment Of Device Component 21 21
Improper or Incorrect Procedure or Method 21 21
Device Difficult to Setup or Prepare 20 20
Delivered as Unsterile Product 20 20
Device Damaged Prior to Use 19 19
Defective Component 18 18
Component Missing 18 18
Scratched Material 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Failure To Adhere Or Bond 17 17
Premature Separation 17 17
Difficult or Delayed Positioning 16 16
Device Damaged by Another Device 15 15
Material Separation 14 14
Dull, Blunt 12 12
Bent 11 11
Unsealed Device Packaging 10 10
Compatibility Problem 10 10
Flaked 9 9
Inaccurate Information 9 9
Difficult or Delayed Separation 8 8
Entrapment of Device 8 8
Peeled/Delaminated 8 8
Misassembled 8 8
Difficult to Open or Remove Packaging Material 8 8
Microbial Contamination of Device 7 7
Contamination /Decontamination Problem 7 7
Disconnection 7 7
Illegible Information 7 7
Activation, Positioning or Separation Problem 6 6
Failure to Advance 6 6
Expiration Date Error 5 5
Failure to Align 5 5
Device Disinfection Or Sterilization Issue 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8479 8479
No Code Available 7129 7129
Joint Dislocation 4121 4121
Injury 3700 3700
Unspecified Infection 3680 3689
No Information 3163 3163
Foreign Body Reaction 2159 2159
Test Result 1939 1939
Inflammation 1847 1847
Discomfort 1586 1586
Tissue Damage 1503 1503
Failure of Implant 1386 1481
Reaction 1371 1371
Osteolysis 1311 1311
Bone Fracture(s) 1241 1255
No Clinical Signs, Symptoms or Conditions 1161 1161
Not Applicable 1102 1102
Ambulation Difficulties 1013 1013
Insufficient Information 994 994
Inadequate Osseointegration 984 984
No Known Impact Or Consequence To Patient 980 980
Limited Mobility Of The Implanted Joint 926 926
No Consequences Or Impact To Patient 865 865
Metal Related Pathology 730 730
Host-Tissue Reaction 729 729
Hypersensitivity/Allergic reaction 727 727
Loss of Range of Motion 662 662
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 516 516
Joint Laxity 482 482
Fall 445 445
Necrosis 417 417
Swelling 328 328
Edema 319 319
Distress 311 311
Joint Disorder 310 310
Weakness 265 265
No Patient Involvement 254 254
Hematoma 251 251
Ossification 232 232
Swelling/ Edema 232 232
Synovitis 226 226
Adhesion(s) 220 220
Hip Fracture 216 216
Unspecified Tissue Injury 192 192
Scar Tissue 178 197
Impaired Healing 154 162
Cyst(s) 152 152
Wound Dehiscence 150 150
Fatigue 148 148
Deformity/ Disfigurement 144 144
Death 138 138
Thrombosis 135 135
Hemorrhage/Bleeding 123 123
Pulmonary Embolism 122 122
Muscular Rigidity 121 121
Local Reaction 121 121
Anxiety 118 118
Blood Loss 110 110
Osteopenia/ Osteoporosis 109 109
Bacterial Infection 106 106
Nerve Damage 101 101
Physical Asymmetry 95 95
Fever 81 81
Fluid Discharge 76 76
Depression 67 67
Hypoesthesia 67 67
Sepsis 65 65
Implant Pain 62 62
Muscle/Tendon Damage 53 53
Post Operative Wound Infection 53 53
Fibrosis 52 52
Myocardial Infarction 50 50
Abscess 50 50
Foreign Body In Patient 49 49
Numbness 46 46
Rash 45 45
Erosion 44 44
Cardiac Arrest 43 43
Headache 43 43
Pocket Erosion 43 43
Unequal Limb Length 43 43
Toxicity 42 42
Thrombosis/Thrombus 41 41
Erythema 39 39
Anemia 38 38
Device Embedded In Tissue or Plaque 38 38
Limb Fracture 37 37
Scarring 37 37
Renal Failure 36 36
Seroma 32 32
Neuropathy 32 32
Cellulitis 32 32
Memory Loss/Impairment 31 31
Infarction, Cerebral 30 30
Irritation 29 29
Pneumonia 27 27
Tinnitus 26 26
Encephalopathy 24 24
Arthritis 24 24
Burning Sensation 24 24

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
23 Zimmer, Inc. II Sep-07-2023
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