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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
BIOCOMPOSITES LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 269 269
2021 107 107
2022 99 99
2023 49 49
2024 144 144
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 172 172
Biocompatibility 102 102
Loss of Osseointegration 76 76
Device-Device Incompatibility 59 59
Break 56 56
Material Twisted/Bent 48 48
Device Dislodged or Dislocated 39 39
Insufficient Information 34 34
Loose or Intermittent Connection 28 28
Appropriate Term/Code Not Available 21 21
Device Contaminated During Manufacture or Shipping 16 16
Scratched Material 14 14
Tear, Rip or Hole in Device Packaging 13 13
Material Deformation 13 13
Fracture 12 12
Naturally Worn 11 11
Packaging Problem 10 10
Migration 9 9
Detachment of Device or Device Component 9 9
Corroded 8 8
Osseointegration Problem 7 7
Computer System Security Problem 7 7
Physical Resistance/Sticking 7 7
Material Integrity Problem 7 7
Degraded 5 5
Patient Device Interaction Problem 5 5
Defective Device 4 4
Malposition of Device 4 4
Mechanical Jam 4 4
Compatibility Problem 4 4
Unstable 4 4
Material Fragmentation 3 3
Failure to Osseointegrate 3 3
Inadequacy of Device Shape and/or Size 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult to Insert 2 2
Unsealed Device Packaging 2 2
Unintended Movement 2 2
Patient-Device Incompatibility 2 2
No Apparent Adverse Event 2 2
Device Damaged Prior to Use 2 2
Crack 2 2
Entrapment of Device 2 2
Difficult to Remove 1 1
Material Discolored 1 1
Use of Device Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Advance 1 1
Device Markings/Labelling Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 119 119
Metal Related Pathology 117 117
Insufficient Information 113 113
No Consequences Or Impact To Patient 107 107
Pain 94 94
Unspecified Infection 67 67
Bone Fracture(s) 36 36
Joint Dislocation 35 35
No Clinical Signs, Symptoms or Conditions 35 35
Failure of Implant 29 29
Inadequate Osseointegration 24 24
Osteolysis 20 20
Injury 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Infiltration into Tissue 15 15
Loss of Range of Motion 12 12
Not Applicable 12 12
Arthralgia 11 11
Ambulation Difficulties 11 11
Leiomyosarcoma 11 11
Fall 9 9
No Known Impact Or Consequence To Patient 7 7
Limited Mobility Of The Implanted Joint 6 6
Foreign Body Reaction 6 6
Swelling/ Edema 5 5
Implant Pain 5 5
Inflammation 5 5
Test Result 5 5
Synovitis 4 4
Edema 4 4
Necrosis 4 4
No Patient Involvement 4 4
Hip Fracture 4 4
Joint Laxity 4 4
Hematoma 3 3
Ossification 3 3
Bacterial Infection 3 3
Discomfort 3 3
Solid Tumour 3 3
Hypersensitivity/Allergic reaction 3 3
Muscle Weakness 2 2
Cyst(s) 2 2
Foreign Body In Patient 2 2
Unspecified Eye / Vision Problem 2 2
Wound Dehiscence 2 2
Toxicity 2 2
Muscle/Tendon Damage 2 2
Headache 1 1
Hemorrhage/Bleeding 1 1
Tinnitus 1 1

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