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


Premarket Reviews
ManufacturerDecision
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 415 415
2020 269 269
2021 107 107
2022 99 99
2023 49 49
2024 143 143
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 244 244
Device-Device Incompatibility 193 193
Material Twisted/Bent 110 110
Biocompatibility 107 107
Break 105 105
Loss of Osseointegration 94 94
Scratched Material 75 75
Device Dislodged or Dislocated 52 52
Insufficient Information 46 46
Naturally Worn 35 35
Fitting Problem 30 30
Loose or Intermittent Connection 30 30
Appropriate Term/Code Not Available 26 26
Physical Resistance/Sticking 24 24
Material Deformation 21 21
Fracture 18 18
Migration 18 18
Device Contaminated During Manufacture or Shipping 16 16
Nonstandard Device 14 14
Tear, Rip or Hole in Device Packaging 13 13
Degraded 12 12
Osseointegration Problem 12 12
Corroded 11 11
Packaging Problem 10 10
Mechanical Jam 9 9
Inadequacy of Device Shape and/or Size 9 9
Detachment of Device or Device Component 8 8
Difficult to Remove 7 7
Entrapment of Device 7 7
Material Integrity Problem 7 7
Computer System Security Problem 7 7
Patient Device Interaction Problem 7 7
Connection Problem 6 6
Malposition of Device 6 6
Patient-Device Incompatibility 5 5
Defective Device 4 4
Unstable 4 4
Difficult to Insert 4 4
Compatibility Problem 4 4
Use of Device Problem 3 3
Failure to Osseointegrate 3 3
Mechanical Problem 3 3
Unintended Movement 3 3
Crack 3 3
Material Fragmentation 3 3
Migration or Expulsion of Device 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Device Damaged Prior to Use 2 2
Material Discolored 2 2
Loss of or Failure to Bond 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 320 320
No Code Available 226 226
Pain 163 163
Insufficient Information 113 113
Metal Related Pathology 113 113
Unspecified Infection 93 93
Not Applicable 60 60
Injury 49 49
Test Result 47 47
Bone Fracture(s) 45 45
Joint Dislocation 42 42
Inadequate Osseointegration 42 42
No Clinical Signs, Symptoms or Conditions 35 35
Osteolysis 32 32
Failure of Implant 31 31
Tissue Damage 21 21
Discomfort 21 21
Foreign Body Reaction 20 20
Loss of Range of Motion 18 18
Limited Mobility Of The Implanted Joint 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Infiltration into Tissue 15 15
Inflammation 13 13
Ambulation Difficulties 12 12
Fall 12 12
Arthralgia 11 11
No Known Impact Or Consequence To Patient 11 11
Leiomyosarcoma 11 11
No Information 8 8
Edema 8 8
Necrosis 6 6
Hematoma 6 6
Hypersensitivity/Allergic reaction 6 6
Hip Fracture 5 5
Swelling/ Edema 5 5
Synovitis 5 5
Toxicity 4 4
Implant Pain 4 4
Joint Laxity 4 4
Cyst(s) 4 4
Swelling 4 4
Thrombosis 4 4
No Patient Involvement 4 4
Blood Loss 4 4
Bacterial Infection 3 3
Solid Tumour 3 3
Ossification 3 3
Distress 3 3
Limb Fracture 2 2
Muscle/Tendon Damage 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jul-16-2024
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