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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product CodeKWY
Regulation Number 888.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231526  CORAIL Cemented Femoral Stem
G21, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1260 1260
2021 276 276
2022 208 208
2023 178 178
2024 210 210
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1010 1010
Device Dislodged or Dislocated 444 444
Naturally Worn 134 134
Fracture 111 111
Difficult to Insert 72 72
Insufficient Information 62 62
Migration 56 56
Loss of Osseointegration 49 49
Appropriate Term/Code Not Available 39 39
Loosening of Implant Not Related to Bone-Ingrowth 30 30
Noise, Audible 30 30
Material Erosion 29 29
Detachment of Device or Device Component 27 27
Loss of or Failure to Bond 24 24
Device Contaminated During Manufacture or Shipping 21 21
Degraded 20 20
Corroded 20 20
Osseointegration Problem 19 19
Break 18 18
Unintended Movement 16 16
Malposition of Device 15 15
Patient Device Interaction Problem 15 15
Nonstandard Device 14 14
Use of Device Problem 14 14
Positioning Failure 13 13
Unstable 11 11
Device-Device Incompatibility 9 9
Mechanical Problem 7 7
Separation Failure 7 7
Biocompatibility 6 6
Off-Label Use 6 6
No Apparent Adverse Event 5 5
Fitting Problem 5 5
Mechanical Jam 5 5
Material Integrity Problem 5 5
Positioning Problem 4 4
Failure to Osseointegrate 4 4
Crack 4 4
Loose or Intermittent Connection 4 4
Packaging Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Device Damaged Prior to Use 3 3
Difficult to Remove 3 3
Activation, Positioning or Separation Problem 3 3
Expiration Date Error 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 2 2
Scratched Material 2 2
Separation Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 854 854
Pain 494 494
Joint Dislocation 395 395
Unspecified Infection 332 332
Test Result 171 171
Foreign Body Reaction 156 156
No Clinical Signs, Symptoms or Conditions 138 138
Bone Fracture(s) 119 119
Insufficient Information 117 117
Failure of Implant 110 110
Inadequate Osseointegration 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 73 73
Osteolysis 70 70
Hypersensitivity/Allergic reaction 63 63
Joint Laxity 62 62
Fall 60 60
Discomfort 52 52
Injury 44 44
Edema 42 42
No Consequences Or Impact To Patient 41 41
Limited Mobility Of The Implanted Joint 40 40
Hematoma 39 39
Metal Related Pathology 38 38
No Information 38 38
Ambulation Difficulties 36 36
Necrosis 31 31
No Known Impact Or Consequence To Patient 29 29
Inflammation 27 27
Tissue Damage 23 23
Not Applicable 23 23
Loss of Range of Motion 23 23
Adhesion(s) 21 21
Thrombosis 19 19
Ossification 18 18
Cyst(s) 18 18
No Patient Involvement 18 18
Fatigue 17 17
Hip Fracture 16 16
Nerve Damage 14 14
Hemorrhage/Bleeding 14 14
Weakness 14 14
Pulmonary Embolism 12 12
Osteopenia/ Osteoporosis 12 12
Impaired Healing 12 12
Unspecified Tissue Injury 11 11
Local Reaction 11 11
Swelling/ Edema 10 10
Muscle/Tendon Damage 10 10
Arthralgia 10 10
Scar Tissue 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Exactech, Inc. II Jun-28-2024
3 Smith & Nephew, Inc. II Nov-07-2024
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