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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
Product CodeLWJ
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 452 452
2015 310 310
2016 297 297
2017 312 312
2018 227 227
2019 211 211
2020 189 189
2021 155 155
2022 91 91
2023 72 72
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 509 509
Break 476 476
Fracture 249 249
Adverse Event Without Identified Device or Use Problem 230 230
Device Dislodged or Dislocated 216 216
Corroded 102 102
Loose or Intermittent Connection 101 101
Loss of Osseointegration 83 83
Appropriate Term/Code Not Available 68 68
Naturally Worn 45 45
Metal Shedding Debris 45 45
Dull, Blunt 36 36
Osseointegration Problem 32 32
Migration or Expulsion of Device 29 29
Material Integrity Problem 24 24
Device Operates Differently Than Expected 22 22
Unstable 21 21
Difficult to Remove 18 18
Device Slipped 18 18
Noise, Audible 16 16
Detachment of Device or Device Component 14 14
Mechanical Problem 13 13
Degraded 13 13
Malposition of Device 12 12
Migration 11 11
Compatibility Problem 10 10
Material Fragmentation 10 10
Material Discolored 9 9
Inadequacy of Device Shape and/or Size 8 8
Positioning Problem 8 8
No Apparent Adverse Event 8 8
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Patient Device Interaction Problem 7 7
Mechanical Jam 7 7
Patient-Device Incompatibility 7 7
Detachment Of Device Component 7 7
Failure To Adhere Or Bond 7 7
Device Contamination with Chemical or Other Material 6 6
Use of Device Problem 6 6
Fitting Problem 6 6
Physical Resistance/Sticking 6 6
Packaging Problem 5 5
Material Deformation 5 5
Material Disintegration 5 5
Disassembly 4 4
Crack 4 4
Component Incompatible 4 4
Material Erosion 4 4
Device Appears to Trigger Rejection 4 4
Device Difficult to Setup or Prepare 4 4
Connection Problem 4 4
Biocompatibility 4 4
Component Missing 4 4
Scratched Material 4 4
Material Separation 3 3
Loss of or Failure to Bond 3 3
Entrapment of Device 3 3
Collapse 2 2
Difficult to Insert 2 2
Nonstandard Device 2 2
Failure to Osseointegrate 2 2
Tear, Rip or Hole in Device Packaging 2 2
Defective Device 2 2
Device Packaging Compromised 2 2
Device Fell 2 2
Output Problem 1 1
Mechanics Altered 1 1
Measurement System Incompatibility 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Material Distortion 1 1
Component or Accessory Incompatibility 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Damaged by Another Device 1 1
Failure to Align 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Device Damaged Prior to Use 1 1
Delivered as Unsterile Product 1 1
Device Expiration Issue 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Contamination 1 1
Battery charger, defective 1 1
Bent 1 1
Biofilm coating in Device 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 666 666
Pain 386 386
No Code Available 227 227
Unspecified Infection 186 186
Reaction 172 172
Bone Fracture(s) 170 170
No Known Impact Or Consequence To Patient 150 150
Insufficient Information 73 73
Failure of Implant 70 70
Injury 66 66
Joint Dislocation 59 59
No Consequences Or Impact To Patient 53 53
Inadequate Osseointegration 52 52
No Clinical Signs, Symptoms or Conditions 52 52
Fall 41 41
Osteolysis 36 36
Toxicity 34 34
Ambulation Difficulties 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Metal Related Pathology 23 23
Hip Fracture 22 22
Loss of Range of Motion 21 21
Inflammation 20 20
Test Result 20 20
Discomfort 19 19
Patient Problem/Medical Problem 18 18
Limited Mobility Of The Implanted Joint 17 17
Swelling 17 17
Foreign Body Reaction 17 17
Complaint, Ill-Defined 16 16
Tissue Damage 16 16
Necrosis 13 13
Foreign Body In Patient 12 12
Joint Disorder 11 11
Joint Laxity 11 11
Limb Fracture 11 11
Not Applicable 10 10
Hypersensitivity/Allergic reaction 10 10
Death 9 9
Synovitis 9 9
Seroma 8 8
Host-Tissue Reaction 8 8
Ossification 7 7
Hematoma 7 7
Fluid Discharge 7 7
Unequal Limb Length 6 6
Fatigue 6 6
Bacterial Infection 6 6
Rash 5 5
Sepsis 5 5
Swelling/ Edema 5 5
Missing Value Reason 5 5
Numbness 5 5
No Patient Involvement 5 5
Device Embedded In Tissue or Plaque 4 4
Unspecified Tissue Injury 4 4
Scar Tissue 4 4
Edema 4 4
Wound Dehiscence 4 4
Purulent Discharge 3 3
Fever 3 3
Hemorrhage/Bleeding 3 3
Muscular Rigidity 3 3
Distress 3 3
Fibrosis 3 3
Sleep Dysfunction 3 3
Blood Loss 3 3
Impaired Healing 2 2
Shaking/Tremors 2 2
Non-union Bone Fracture 2 2
Implant Pain 2 2
Thrombosis/Thrombus 2 2
Anxiety 2 2
Arthralgia 2 2
Weakness 2 2
Skin Discoloration 2 2
Cyst(s) 2 2
Infiltration into Tissue 2 2
Dyspnea 2 2
Erosion 2 2
Arthritis 2 2
Aspiration/Inhalation 2 2
Adhesion(s) 2 2
Anemia 1 1
Arrhythmia 1 1
Autoimmune Disorder 1 1
Failure to Anastomose 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Infarction, Cerebral 1 1
Embolism 1 1
Encephalopathy 1 1
Keratitis 1 1
Memory Loss/Impairment 1 1
Muscle Weakness 1 1
Hair Loss 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Thrombus 1 1
Thyroid Problems 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jan-31-2024
2 MicroPort Orthopedics Inc. I Sep-18-2020
3 MicroPort Orthopedics Inc. II Sep-09-2020
4 MicroPort Orthopedics Inc. II Aug-18-2016
5 Stelkast Co II Mar-31-2009
6 Stelkast Co II Jan-28-2009
7 Stryker Howmedica Osteonics Corp. II Aug-18-2009
8 Zimmer Inc. II Jul-06-2009
9 Zimmer, Inc. II Feb-20-2014
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