Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

MDR Year MDR Reports MDR Events
2019 335 335
2020 1046 1046
2021 1206 1206
2022 886 886
2023 289 289
2024 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1695 1695
Fracture 496 496
Adverse Event Without Identified Device or Use Problem 277 277
Material Twisted/Bent 210 210
Crack 191 191
Material Deformation 156 156
Naturally Worn 115 115
Connection Problem 98 98
Defective Device 73 73
Material Fragmentation 65 65
Device Dislodged or Dislocated 63 63
Insufficient Information 61 61
Detachment of Device or Device Component 60 60
Loose or Intermittent Connection 51 51
Mechanical Problem 48 48
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Mechanics Altered 37 37
Biocompatibility 34 34
Mechanical Jam 30 30
Corroded 27 27
Unstable 27 27
Flaked 26 26
Degraded 21 21
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Physical Resistance/Sticking 18 18
Material Separation 18 18
Scratched Material 17 17
Peeled/Delaminated 16 16
Component Missing 15 15
Material Disintegration 14 14
Appropriate Term/Code Not Available 10 10
Material Erosion 9 9
Migration 9 9
Premature Separation 8 8
Inadequacy of Device Shape and/or Size 8 8
Loss of Osseointegration 8 8
Deformation Due to Compressive Stress 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
Solder Joint Fracture 5 5
Material Integrity Problem 5 5
Misconnection 4 4
Noise, Audible 4 4
Patient Device Interaction Problem 4 4
Malposition of Device 4 4
Loss of or Failure to Bond 4 4
Off-Label Use 4 4
Device Damaged Prior to Use 4 4
Material Split, Cut or Torn 4 4
Sharp Edges 4 4
Failure to Clean Adequately 3 3
Defective Component 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Use of Device Problem 3 3
Problem with Sterilization 3 3
Migration or Expulsion of Device 3 3
Separation Failure 3 3
Unintended Movement 3 3
No Apparent Adverse Event 3 3
Incomplete Coaptation 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Appears to Trigger Rejection 2 2
Difficult to Remove 2 2
Delivered as Unsterile Product 2 2
Unclear Information 2 2
Device Fell 2 2
Activation Problem 1 1
Device Slipped 1 1
Failure to Reset 1 1
Unraveled Material 1 1
Failure to Osseointegrate 1 1
Misassembled 1 1
Difficult to Insert 1 1
Disconnection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Osseointegration Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2486 2486
No Known Impact Or Consequence To Patient 353 353
No Patient Involvement 237 237
No Consequences Or Impact To Patient 207 207
No Code Available 104 104
Injury 103 103
Pain 91 91
Joint Dislocation 90 90
Failure of Implant 87 87
Unspecified Infection 74 74
Insufficient Information 59 59
No Information 46 46
Bone Fracture(s) 43 43
Test Result 41 41
Metal Related Pathology 35 35
Tissue Damage 34 34
Foreign Body In Patient 25 25
Osteolysis 23 23
Inadequate Osseointegration 22 22
Inflammation 18 18
Limited Mobility Of The Implanted Joint 17 17
Foreign Body Reaction 14 14
Loss of Range of Motion 14 14
Discomfort 12 12
Deformity/ Disfigurement 11 11
Thrombosis/Thrombus 10 10
Fall 9 9
Ambulation Difficulties 8 8
Reaction 7 7
Hip Fracture 7 7
Swelling 6 6
Subluxation 6 6
Device Embedded In Tissue or Plaque 5 5
Post Operative Wound Infection 5 5
Bacterial Infection 5 5
Fatigue 4 4
Death 4 4
Perforation 4 4
Nerve Damage 4 4
Non-union Bone Fracture 4 4
Swelling/ Edema 4 4
Not Applicable 3 3
Joint Laxity 3 3
Malunion of Bone 3 3
Muscle/Tendon Damage 3 3
Impaired Healing 3 3
Confusion/ Disorientation 3 3
Fluid Discharge 3 3
Local Reaction 3 3
Scar Tissue 3 3
Scarring 3 3
Necrosis 3 3
Arthritis 2 2
Cyst(s) 2 2
Host-Tissue Reaction 2 2
Ossification 2 2
Pulmonary Embolism 2 2
Osteopenia/ Osteoporosis 2 2
Joint Disorder 2 2
Synovitis 2 2
Dizziness 2 2
Balance Problems 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
Implant Pain 2 2
Movement Disorder 1 1
Fibrosis 1 1
Full thickness (Third Degree) Burn 1 1
Unequal Limb Length 1 1
Unspecified Musculoskeletal problem 1 1
Solid Tumour 1 1
Limb Fracture 1 1
Depression 1 1
Hypoesthesia 1 1
Arthralgia 1 1
Thrombosis 1 1
Vertigo 1 1
Weakness 1 1
Toxoplasmosis, Acquired 1 1
Ulcer 1 1
Anxiety 1 1
Needle Stick/Puncture 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Abscess 1 1
Adhesion(s) 1 1
Anemia 1 1
Arrhythmia 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Purulent Discharge 1 1
Edema 1 1
Emotional Changes 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Infiltration into Tissue 1 1
Memory Loss/Impairment 1 1
Muscular Rigidity 1 1
Nausea 1 1
Seroma 1 1

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
-
-