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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
2020 4537 4537
2021 2066 2066
2022 1620 1620
2023 1482 1482
2024 1168 1171

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5396 5396
Device Dislodged or Dislocated 1007 1007
Naturally Worn 862 862
Insufficient Information 463 463
Device Contaminated During Manufacture or Shipping 454 454
Material Erosion 383 383
Fracture 380 380
Osseointegration Problem 330 330
Loss of Osseointegration 319 319
Migration 252 255
Corroded 206 206
Loosening of Implant Not Related to Bone-Ingrowth 186 186
Noise, Audible 178 178
Patient Device Interaction Problem 166 166
Packaging Problem 164 164
Use of Device Problem 163 163
Appropriate Term/Code Not Available 155 155
Manufacturing, Packaging or Shipping Problem 128 128
Malposition of Device 126 126
Degraded 121 121
Tear, Rip or Hole in Device Packaging 118 118
Difficult to Insert 115 115
Biocompatibility 87 87
Unstable 65 65
Patient-Device Incompatibility 63 63
Material Disintegration 54 54
Loss of or Failure to Bond 50 50
Detachment of Device or Device Component 47 47
Unintended Movement 41 41
Positioning Failure 37 37
Difficult to Remove 37 37
Inadequacy of Device Shape and/or Size 35 35
Device-Device Incompatibility 30 30
Separation Failure 28 28
Off-Label Use 28 28
Break 27 27
Nonstandard Device 21 21
Material Integrity Problem 21 21
No Apparent Adverse Event 17 17
Mechanical Problem 15 15
Physical Resistance/Sticking 10 10
Loose or Intermittent Connection 10 10
Delivered as Unsterile Product 10 10
Failure to Osseointegrate 9 9
Illegible Information 8 8
Improper or Incorrect Procedure or Method 8 8
Material Deformation 8 8
Migration or Expulsion of Device 7 7
Inaccurate Information 7 7
Output Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4153 4153
No Code Available 2785 2785
Foreign Body Reaction 2013 2013
Metal Related Pathology 1471 1471
Unspecified Infection 1039 1039
Osteolysis 848 848
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 817 817
Hypersensitivity/Allergic reaction 812 812
Joint Dislocation 780 780
Test Result 677 677
No Clinical Signs, Symptoms or Conditions 676 676
Insufficient Information 619 619
Discomfort 608 608
Inadequate Osseointegration 559 559
Swelling/ Edema 476 476
Failure of Implant 436 436
Unspecified Tissue Injury 415 415
Distress 398 398
Bone Fracture(s) 393 393
Ambulation Difficulties 382 382
Loss of Range of Motion 362 362
Inflammation 308 308
No Patient Involvement 293 293
Necrosis 292 292
Joint Laxity 283 283
Adhesion(s) 283 283
No Information 280 280
Edema 251 251
No Known Impact Or Consequence To Patient 234 234
Synovitis 229 229
Deformity/ Disfigurement 224 224
Limited Mobility Of The Implanted Joint 222 222
Scar Tissue 197 197
Tissue Damage 182 182
Fall 175 175
Fatigue 162 162
Cyst(s) 160 160
Anxiety 152 152
Reaction 145 145
Injury 144 144
Muscle/Tendon Damage 130 130
Ossification 115 115
Local Reaction 109 109
Muscular Rigidity 105 105
Physical Asymmetry 105 105
Depression 83 83
Hematoma 78 78
Hemorrhage/Bleeding 78 78
Weakness 74 74
Osteopenia/ Osteoporosis 69 69

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
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