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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


Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 14
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 16483 16483
2015 12353 12353
2016 7869 7869
2017 6843 6843
2018 6387 6387
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
Insufficient Information 26760 26760
Adverse Event Without Identified Device or Use Problem 12240 12240
Appropriate Term/Code Not Available 7551 7551
Naturally Worn 6045 6045
Device Dislodged or Dislocated 4552 4552
Metal Shedding Debris 4058 4058
Loss of Osseointegration 3296 3296
Corroded 2006 2006
Noise, Audible 1982 1982
Nonstandard Device 1674 1674
Material Erosion 1530 1530
Fracture 1334 1334
Migration or Expulsion of Device 1093 1093
Malposition of Device 1084 1084
Loose or Intermittent Connection 1037 1037
Material Disintegration 867 867
Osseointegration Problem 815 815
Device Operates Differently Than Expected 703 703
Device Slipped 603 603
Device Contaminated During Manufacture or Shipping 567 567
Migration 550 550
Break 487 487
Use of Device Problem 459 459
Patient-Device Incompatibility 416 416
Unstable 406 406
Biocompatibility 368 368
Degraded 342 342
Loss of or Failure to Bond 332 332
Disassembly 275 275
Loosening of Implant Not Related to Bone-Ingrowth 261 261
Material Integrity Problem 226 226
Packaging Problem 220 220
Difficult to Remove 219 219
Tear, Rip or Hole in Device Packaging 177 177
Patient Device Interaction Problem 176 176
Inadequacy of Device Shape and/or Size 165 165
Mechanical Problem 156 156
Difficult to Insert 145 145
Separation Failure 128 128
Compatibility Problem 103 103
Positioning Problem 98 98
Detachment of Device or Device Component 97 97
Device-Device Incompatibility 89 89
Manufacturing, Packaging or Shipping Problem 78 78
Unintended Movement 77 77
Device Packaging Compromised 75 75
Failure to Osseointegrate 75 75
Fitting Problem 65 65
Device Contamination with Chemical or Other Material 61 61
Failure To Adhere Or Bond 55 55
No Apparent Adverse Event 52 52
Positioning Failure 51 51
Material Separation 45 45
Material Deformation 40 40
Material Discolored 39 39
Detachment Of Device Component 38 38
Separation Problem 36 36
Off-Label Use 35 35
Mechanical Jam 31 31
Disconnection 26 26
Delivered as Unsterile Product 23 23
Defective Device 23 23
Improper or Incorrect Procedure or Method 22 22
Material Protrusion/Extrusion 21 21
Scratched Material 21 21
Crack 20 20
Component Missing 19 19
Material Twisted/Bent 18 18
Material Fragmentation 17 17
Difficult To Position 17 17
Entrapment of Device 14 14
Device Issue 14 14
Physical Resistance/Sticking 14 14
Failure to Align 13 13
Device Markings/Labelling Problem 13 13
Failure to Disconnect 13 13
Product Quality Problem 13 13
Unsealed Device Packaging 13 13
Particulates 12 12
Flaked 11 11
Defective Component 11 11
Difficult or Delayed Separation 11 11
Connection Problem 10 10
Peeled/Delaminated 10 10
Problem with Sterilization 10 10
Component or Accessory Incompatibility 9 9
Bent 8 8
Illegible Information 8 8
Improper Chemical Reaction 8 8
Output Problem 7 7
Inaccurate Information 7 7
Shipping Damage or Problem 7 7
Contamination /Decontamination Problem 7 7
Implant, removal of 7 7
Sticking 6 6
Fluid/Blood Leak 6 6
Collapse 6 6
Therapeutic or Diagnostic Output Failure 6 6
Difficult or Delayed Positioning 5 5
Expiration Date Error 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 34836 34837
No Code Available 21502 21504
No Information 9350 9350
Foreign Body Reaction 7608 7608
Discomfort 7593 7593
Tissue Damage 5856 5856
Host-Tissue Reaction 5796 5796
Inflammation 4664 4664
Unspecified Infection 4587 4588
Toxicity 4373 4373
Osteolysis 4298 4298
Test Result 4075 4075
Loss of Range of Motion 3486 3486
Reaction 3452 3452
Limited Mobility Of The Implanted Joint 3143 3143
Ambulation Difficulties 2998 2998
Injury 2815 2815
Joint Dislocation 2756 2756
Swelling 2194 2194
Inadequate Osseointegration 1846 1847
Hypersensitivity/Allergic reaction 1821 1821
Not Applicable 1773 1773
Bone Fracture(s) 1737 1737
Complaint, Ill-Defined 1507 1507
Metal Related Pathology 1496 1496
Necrosis 1207 1207
Distress 961 961
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 935 935
Synovitis 878 878
Weakness 873 873
Edema 819 819
Cyst(s) 782 782
No Known Impact Or Consequence To Patient 752 752
Failure of Implant 660 660
Adhesion(s) 574 574
Insufficient Information 563 563
No Clinical Signs, Symptoms or Conditions 543 543
No Consequences Or Impact To Patient 538 538
Scar Tissue 519 519
No Patient Involvement 516 516
Swelling/ Edema 511 511
Deformity/ Disfigurement 505 505
Disability 505 505
Fall 472 472
Unspecified Tissue Injury 439 439
Anxiety 428 428
Muscular Rigidity 403 403
Fatigue 377 377
Fluid Discharge 376 376
Ossification 362 362
Hematoma 322 322
Local Reaction 313 313
Osteopenia/ Osteoporosis 303 303
Muscle Weakness 300 300
Joint Swelling 291 291
Joint Laxity 270 270
Death 229 229
Joint Disorder 200 200
Thrombosis 190 190
Depression 181 181
Hip Fracture 168 168
Pulmonary Embolism 168 168
Hemorrhage/Bleeding 167 167
Fibrosis 161 161
Erosion 153 153
Blood Loss 146 146
Scarring 145 145
Nerve Damage 145 145
Numbness 143 143
Muscle/Tendon Damage 131 131
Pocket Erosion 117 117
Physical Asymmetry 110 110
Rash 106 106
Irritation 95 95
Wound Dehiscence 93 93
Abscess 92 92
Hypoesthesia 87 87
Cardiac Arrest 81 81
Fever 81 81
Malaise 79 79
Headache 78 78
Sepsis 77 77
Chemical Exposure 72 72
Memory Loss/Impairment 71 71
Impaired Healing 68 68
Damage to Ligament(s) 66 66
Infarction, Cerebral 65 65
Hearing Impairment 63 63
Foreign Body In Patient 63 63
Myocardial Infarction 62 62
Weight Changes 60 60
Seroma 59 59
Skin Irritation 57 57
Calcium Deposits/Calcification 55 55
Purulent Discharge 53 53
Bacterial Infection 53 53
Tinnitus 51 51
Sleep Dysfunction 51 51
Arthralgia 50 50
Burning Sensation 50 50

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Nov-21-2023
2 Biomet, Inc. II Aug-12-2021
3 Biomet, Inc. II Feb-17-2015
4 Biomet, Inc. II Nov-27-2012
5 Biomet, Inc. II Nov-21-2012
6 Biomet, Inc. II Jun-08-2011
7 Biomet, Inc. II Mar-07-2011
8 DePuy Orthopaedics, Inc. II Jan-07-2021
9 DePuy Orthopaedics, Inc. II Jul-21-2014
10 Depuy Orthopaedics, Inc. II Mar-24-2011
11 Depuy Orthopaedics, Inc. II Jul-17-2010
12 Encore Medical, LP II Sep-19-2023
13 Encore Medical, Lp II Feb-11-2017
14 Wright Medical Technology Inc II Feb-14-2012
15 Zimmer Biomet, Inc. II Nov-07-2019
16 Zimmer Biomet, Inc. II Dec-19-2018
17 Zimmer Biomet, Inc. II Aug-14-2018
18 Zimmer Biomet, Inc. II Dec-29-2017
19 Zimmer Biomet, Inc. II Feb-22-2016
20 Zimmer Gmbh II Feb-20-2015
21 Zimmer, Inc. I Jun-08-2015
22 Zimmer, Inc. II Oct-25-2013
23 Zimmer, Inc. II Nov-06-2012
24 Zimmer, Inc. II Aug-16-2012
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