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

MDR Year MDR Reports MDR Events
2021 155 158
2022 91 93
2023 72 72
2024 54 54
2025 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 112 114
Break 81 81
Fracture 38 38
Device Dislodged or Dislocated 36 37
Insufficient Information 35 35
Osseointegration Problem 20 22
Loss of Osseointegration 19 19
Mechanical Jam 16 16
Corroded 14 14
Detachment of Device or Device Component 14 14
Naturally Worn 8 8
Appropriate Term/Code Not Available 8 8
Migration 7 7
Degraded 7 7
Mechanical Problem 6 6
No Apparent Adverse Event 6 6
Noise, Audible 5 5
Biocompatibility 5 5
Device Appears to Trigger Rejection 4 4
Physical Resistance/Sticking 4 4
Use of Device Problem 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Tear, Rip or Hole in Device Packaging 3 3
Delivered as Unsterile Product 3 3
Failure to Osseointegrate 3 3
Material Fragmentation 3 3
Difficult to Remove 3 3
Packaging Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Fell 2 2
Patient-Device Incompatibility 2 2
Malposition of Device 2 2
Loose or Intermittent Connection 2 2
Unstable 2 2
Scratched Material 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Difficult to Insert 1 1
Positioning Problem 1 1
Measurement System Incompatibility 1 1
Defective Device 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Material Disintegration 1 1
Crack 1 1
Output Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 99 100
No Clinical Signs, Symptoms or Conditions 65 65
Failure of Implant 53 53
Pain 52 56
Bone Fracture(s) 46 46
Unspecified Infection 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 26
Inadequate Osseointegration 22 24
Metal Related Pathology 20 21
Joint Laxity 12 13
Limb Fracture 11 12
Osteolysis 11 11
Foreign Body Reaction 11 13
Fall 10 11
Loss of Range of Motion 10 11
Hypersensitivity/Allergic reaction 7 9
Hip Fracture 7 7
Joint Dislocation 7 7
Discomfort 7 9
Bacterial Infection 5 5
Unequal Limb Length 5 5
Wound Dehiscence 4 4
Swelling/ Edema 4 5
Necrosis 4 5
Unspecified Tissue Injury 4 6
Ambulation Difficulties 3 5
Synovitis 3 3
Foreign Body In Patient 3 3
Distress 2 4
Hemorrhage/Bleeding 2 2
Subluxation 2 2
Thrombosis/Thrombus 2 2
Fever 2 2
Ossification 2 3
Implant Pain 2 2
Muscular Rigidity 1 2
Paresthesia 1 2
Post Traumatic Wound Infection 1 1
Depression 1 2
Numbness 1 2
Osteopenia/ Osteoporosis 1 1
Keratitis 1 1
Dyspnea 1 2
Purulent Discharge 1 1
Anemia 1 1
Inflammation 1 1
Muscle/Tendon Damage 1 2
Anxiety 1 2
Non-union Bone Fracture 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jan-31-2024
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