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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
Product CodeJDG
Regulation Number 888.3360
Device Class 2


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

MDR Year MDR Reports MDR Events
2018 452 452
2019 336 336
2020 1046 1046
2021 1209 1209
2022 897 897
2023 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1677 1677
Fracture 342 342
Adverse Event Without Identified Device or Use Problem 341 341
Insufficient Information 267 267
Material Twisted/Bent 209 209
Crack 191 191
Material Deformation 159 159
Naturally Worn 127 127
Connection Problem 98 98
Device Dislodged or Dislocated 93 93
Defective Device 73 73
Material Fragmentation 64 64
Loose or Intermittent Connection 53 53
Detachment of Device or Device Component 51 51
Mechanical Problem 49 49
Corroded 41 41
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Biocompatibility 37 37
Mechanics Altered 37 37
Appropriate Term/Code Not Available 36 36
Unstable 31 31
Mechanical Jam 30 30
Degraded 27 27
Flaked 26 26
Material Erosion 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Migration 18 18
Material Separation 18 18
Scratched Material 17 17
Loss of Osseointegration 17 17
Component Missing 16 16
Peeled/Delaminated 16 16
Material Disintegration 15 15
Physical Resistance/Sticking 15 15
Noise, Audible 11 11
Loss of or Failure to Bond 10 10
Migration or Expulsion of Device 9 9
Inadequacy of Device Shape and/or Size 8 8
Malposition of Device 8 8
Activation, Positioning or Separation Problem 8 8
Nonstandard Device 7 7
Failure to Align 7 7
Premature Separation 7 7
Difficult or Delayed Separation 6 6
Solder Joint Fracture 6 6
Deformation Due to Compressive Stress 6 6
Positioning Problem 5 5
Material Integrity Problem 5 5
Positioning Failure 5 5
Difficult to Insert 4 4
Misconnection 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Osseointegration Problem 4 4
No Apparent Adverse Event 4 4
Patient Device Interaction Problem 4 4
Sharp Edges 4 4
Material Split, Cut or Torn 4 4
Failure to Clean Adequately 3 3
Unintended Movement 3 3
Separation Failure 3 3
Defective Component 3 3
Problem with Sterilization 3 3
Use of Device Problem 3 3
Off-Label Use 3 3
Difficult to Remove 3 3
Device Appears to Trigger Rejection 2 2
Metal Shedding Debris 2 2
Failure to Osseointegrate 2 2
Failure To Adhere Or Bond 2 2
Incomplete Coaptation 2 2
Difficult to Open or Close 2 2
Device Damaged by Another Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Fell 2 2
Device Handling Problem 2 2
Activation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device-Device Incompatibility 1 1
Tear, Rip or Hole in Device Packaging 1 1
Disconnection 1 1
Misassembled 1 1
Improper or Incorrect Procedure or Method 1 1
Unraveled Material 1 1
Failure to Reset 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2288 2288
No Known Impact Or Consequence To Patient 370 370
No Patient Involvement 238 238
Pain 219 219
No Consequences Or Impact To Patient 215 215
Injury 186 186
No Code Available 163 163
Joint Dislocation 117 117
Unspecified Infection 108 108
No Information 107 107
Failure of Implant 85 85
Inflammation 65 65
Test Result 64 64
Not Applicable 61 61
Tissue Damage 59 59
Insufficient Information 57 57
Bone Fracture(s) 55 55
Reaction 52 52
Inadequate Osseointegration 38 38
Discomfort 38 38
Osteolysis 38 38
Metal Related Pathology 34 34
Limited Mobility Of The Implanted Joint 28 28
Foreign Body In Patient 24 24
Loss of Range of Motion 21 21
Foreign Body Reaction 20 20
Deformity/ Disfigurement 15 15
Ambulation Difficulties 14 14
Fall 11 11
Swelling 11 11
Thrombosis/Thrombus 9 9
Bacterial Infection 9 9
Blood Loss 9 9
Local Reaction 8 8
Hip Fracture 8 8
Impaired Healing 8 8
Necrosis 7 7
Hypersensitivity/Allergic reaction 6 6
Distress 6 6
Post Operative Wound Infection 6 6
Death 6 6
Subluxation 6 6
Thrombosis 5 5
Fatigue 5 5
Wound Dehiscence 5 5
Host-Tissue Reaction 5 5
Perforation 4 4
Device Embedded In Tissue or Plaque 4 4
Depression 4 4
Hematoma 4 4
Non-union Bone Fracture 4 4
Scar Tissue 4 4
Confusion/ Disorientation 4 4
Malunion of Bone 3 3
Cyst(s) 3 3
Weakness 3 3
Infiltration into Tissue 3 3
Muscle/Tendon Damage 3 3
Swelling/ Edema 3 3
Fluid Discharge 3 3
Nerve Damage 3 3
Scarring 3 3
Unequal Limb Length 3 3
Synovitis 2 2
Dizziness 2 2
Peroneal Nerve Palsy 2 2
Balance Problems 2 2
Rupture 2 2
Toxicity 2 2
Osteopenia/ Osteoporosis 2 2
Joint Laxity 2 2
Joint Disorder 2 2
Urinary Tract Infection 2 2
Ossification 2 2
Arthritis 2 2
Nausea 2 2
Cellulitis 2 2
Implant Pain 2 2
Arrhythmia 1 1
Muscular Rigidity 1 1
Arthralgia 1 1
Unspecified Tissue Injury 1 1
Movement Disorder 1 1
Pulmonary Embolism 1 1
Muscle Spasm(s) 1 1
Vertigo 1 1
Adhesion(s) 1 1
Respiratory Distress 1 1
Anxiety 1 1
Ventilator Dependent 1 1
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1
Fibrosis 1 1
Limb Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Anemia 1 1
Emotional Changes 1 1
Ulcer 1 1
Toxoplasmosis, Acquired 1 1
Joint Swelling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-17-2022
2 Howmedica Osteonics Corp. II Nov-30-2021
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