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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 uncemented acetabular component)
Product CodeKWA
Regulation Number 888.3330
Device Class 3

MDR Year MDR Reports MDR Events
2019 7633 7633
2020 4536 4536
2021 2063 2063
2022 1620 1620
2023 1478 1478
2024 292 292

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7995 7995
Device Dislodged or Dislocated 1880 1880
Naturally Worn 1865 1865
Loss of Osseointegration 1031 1031
Insufficient Information 1025 1025
Fracture 604 604
Osseointegration Problem 597 597
Device Contaminated During Manufacture or Shipping 520 520
Material Erosion 518 518
Migration 458 458
Corroded 415 415
Use of Device Problem 354 354
Biocompatibility 320 320
Noise, Audible 306 306
Malposition of Device 290 290
Loosening of Implant Not Related to Bone-Ingrowth 223 223
Appropriate Term/Code Not Available 215 215
Degraded 204 204
Packaging Problem 178 178
Patient Device Interaction Problem 170 170
Loss of or Failure to Bond 167 167
Nonstandard Device 153 153
Material Disintegration 140 140
Tear, Rip or Hole in Device Packaging 136 136
Difficult to Insert 126 126
Unstable 115 115
Break 92 92
Manufacturing, Packaging or Shipping Problem 76 76
Patient-Device Incompatibility 69 69
Unintended Movement 66 66
Detachment of Device or Device Component 65 65
Difficult to Remove 64 64
Inadequacy of Device Shape and/or Size 61 61
Device-Device Incompatibility 59 59
Loose or Intermittent Connection 51 51
Positioning Failure 49 49
Separation Failure 36 36
No Apparent Adverse Event 36 36
Failure to Osseointegrate 32 32
Off-Label Use 31 31
Migration or Expulsion of Device 27 27
Mechanical Problem 20 20
Material Integrity Problem 20 20
Delivered as Unsterile Product 17 17
Mechanical Jam 15 15
Separation Problem 15 15
Material Twisted/Bent 14 14
Positioning Problem 13 13
Material Deformation 13 13
Physical Resistance/Sticking 13 13
Fitting Problem 13 13
Difficult or Delayed Separation 11 11
Scratched Material 10 10
Problem with Sterilization 10 10
Improper or Incorrect Procedure or Method 9 9
Flaked 8 8
Material Fragmentation 8 8
Illegible Information 8 8
Inaccurate Information 7 7
Output Problem 7 7
Unsealed Device Packaging 7 7
Shipping Damage or Problem 7 7
Material Separation 6 6
Defective Device 6 6
Contamination /Decontamination Problem 6 6
Expiration Date Error 5 5
Difficult or Delayed Positioning 5 5
Difficult to Open or Remove Packaging Material 5 5
Missing Information 4 4
Peeled/Delaminated 4 4
Device Markings/Labelling Problem 4 4
Device Damaged Prior to Use 4 4
Difficult to Advance 3 3
Activation, Positioning or Separation Problem 3 3
Biofilm coating in Device 3 3
Misassembled 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Human-Device Interface Problem 2 2
Disconnection 2 2
Crack 2 2
Collapse 2 2
Device Difficult to Setup or Prepare 2 2
Device Appears to Trigger Rejection 2 2
Failure to Disconnect 2 2
Connection Problem 2 2
Defective Component 2 2
Component Missing 2 2
Incomplete or Missing Packaging 2 2
Failure to Align 1 1
Microbial Contamination of Device 1 1
Vibration 1 1
Device Slipped 1 1
Failure to Fire 1 1
Device Ingredient or Reagent Problem 1 1
Device Damaged by Another Device 1 1
Particulates 1 1
Component Incompatible 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7827 7829
Pain 7162 7162
Foreign Body Reaction 2960 2960
Test Result 2243 2243
Unspecified Infection 2091 2092
Joint Dislocation 1473 1473
Osteolysis 1472 1472
Metal Related Pathology 1312 1312
Tissue Damage 1286 1286
Inadequate Osseointegration 1282 1282
Hypersensitivity/Allergic reaction 1172 1172
Discomfort 1133 1133
Injury 850 850
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 837 837
No Information 740 740
Limited Mobility Of The Implanted Joint 729 729
Bone Fracture(s) 706 706
Loss of Range of Motion 628 628
Inflammation 595 595
No Clinical Signs, Symptoms or Conditions 540 540
Insufficient Information 526 526
Necrosis 514 514
Ambulation Difficulties 482 482
Reaction 472 472
Edema 465 465
Failure of Implant 449 449
Swelling/ Edema 446 446
Distress 444 444
Unspecified Tissue Injury 383 383
No Patient Involvement 375 375
Adhesion(s) 372 372
No Known Impact Or Consequence To Patient 335 335
Scar Tissue 267 267
Synovitis 259 259
Deformity/ Disfigurement 252 252
Joint Laxity 252 252
Cyst(s) 230 230
Anxiety 226 226
No Consequences Or Impact To Patient 226 226
Fatigue 222 222
Swelling 208 208
Weakness 201 201
Fall 193 193
Not Applicable 186 186
Local Reaction 185 185
Host-Tissue Reaction 177 177
Ossification 157 157
Hematoma 145 145
Thrombosis 143 143
Hemorrhage/Bleeding 125 125
Muscular Rigidity 123 123
Muscle/Tendon Damage 123 123
Pulmonary Embolism 122 122
Depression 112 112
Physical Asymmetry 96 96
Osteopenia/ Osteoporosis 90 90
Pocket Erosion 86 86
Joint Disorder 80 80
Nerve Damage 69 69
Numbness 67 67
Wound Dehiscence 62 62
Erosion 59 59
Fibrosis 51 51
Cardiac Arrest 45 45
Abscess 45 45
Memory Loss/Impairment 45 45
Blood Loss 44 44
Hypoesthesia 43 43
Myocardial Infarction 43 43
Rash 42 42
Fever 42 42
Sepsis 41 41
Fluid Discharge 40 40
Death 38 38
Limb Fracture 37 37
Stroke/CVA 35 35
Scarring 33 33
Toxicity 32 32
Renal Failure 31 31
Headache 31 31
Hearing Impairment 30 30
Impaired Healing 30 30
Infarction, Cerebral 29 29
Bacterial Infection 27 27
Tinnitus 26 26
Dizziness 25 25
Calcium Deposits/Calcification 25 25
Foreign Body In Patient 25 25
Thrombosis/Thrombus 24 24
Unspecified Musculoskeletal problem 23 23
Post Operative Wound Infection 22 22
Anemia 21 21
Dyspnea 20 20
Heart Failure 19 19
Itching Sensation 19 19
Arthralgia 19 19
Erythema 18 18
Atrial Fibrillation 18 18
Pneumonia 17 17
Hip Fracture 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Nov-21-2023
2 Biomet, Inc. II Aug-12-2021
3 DePuy Orthopaedics, Inc. II Jan-07-2021
4 Encore Medical, LP II Sep-19-2023
5 Zimmer Biomet, Inc. II Nov-07-2019
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