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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, femoral component, cemented, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 334 334
2020 1046 1046
2021 1206 1206
2022 886 886
2023 289 289
2024 301 301
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1726 1726
Fracture 677 677
Adverse Event Without Identified Device or Use Problem 287 287
Material Twisted/Bent 212 212
Crack 192 192
Material Deformation 159 159
Naturally Worn 115 115
Connection Problem 98 98
Device Dislodged or Dislocated 81 81
Defective Device 73 73
Material Fragmentation 70 70
Detachment of Device or Device Component 70 70
Insufficient Information 61 61
Loose or Intermittent Connection 51 51
Mechanical Problem 48 48
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Mechanics Altered 38 38
Biocompatibility 36 36
Mechanical Jam 33 33
Corroded 28 28
Unstable 27 27
Flaked 26 26
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Degraded 22 22
Physical Resistance/Sticking 18 18
Material Separation 18 18
Scratched Material 17 17
Peeled/Delaminated 17 17
Component Missing 15 15
Material Disintegration 14 14
Material Erosion 10 10
Appropriate Term/Code Not Available 10 10
Migration 9 9
Inadequacy of Device Shape and/or Size 9 9
Premature Separation 8 8
Loss of Osseointegration 8 8
Deformation Due to Compressive Stress 8 8
Solder Joint Fracture 8 8
Activation, Positioning or Separation Problem 8 8
Failure to Align 7 7
Nonstandard Device 7 7
Difficult or Delayed Separation 6 6
Positioning Failure 5 5
Material Integrity Problem 5 5
Device Damaged Prior to Use 4 4
Patient Device Interaction Problem 4 4
Noise, Audible 4 4
Unintended Movement 4 4
Sharp Edges 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2702 2702
No Known Impact Or Consequence To Patient 353 353
No Patient Involvement 237 237
No Consequences Or Impact To Patient 207 207
Joint Dislocation 108 108
No Code Available 104 104
Injury 102 102
Failure of Implant 98 98
Pain 96 96
Unspecified Infection 74 74
Insufficient Information 63 63
No Information 46 46
Bone Fracture(s) 45 45
Test Result 41 41
Metal Related Pathology 38 38
Tissue Damage 34 34
Inadequate Osseointegration 27 27
Foreign Body In Patient 25 25
Osteolysis 24 24
Inflammation 18 18
Limited Mobility Of The Implanted Joint 17 17
Loss of Range of Motion 14 14
Foreign Body Reaction 14 14
Fall 12 12
Discomfort 12 12
Deformity/ Disfigurement 11 11
Thrombosis/Thrombus 10 10
Ambulation Difficulties 8 8
Reaction 7 7
Hip Fracture 7 7
Swelling 6 6
Device Embedded In Tissue or Plaque 6 6
Subluxation 6 6
Bacterial Infection 5 5
Post Operative Wound Infection 5 5
Perforation 4 4
Nerve Damage 4 4
Non-union Bone Fracture 4 4
Swelling/ Edema 4 4
Death 4 4
Fatigue 4 4
Hemorrhage/Bleeding 4 4
Muscle/Tendon Damage 4 4
Scarring 3 3
Scar Tissue 3 3
Local Reaction 3 3
Necrosis 3 3
Not Applicable 3 3
Fluid Discharge 3 3
Osteopenia/ Osteoporosis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-17-2022
2 Howmedica Osteonics Corp. II Nov-30-2021
3 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-14-2024
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