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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
Product CodeKWL
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
MANDELL HORWITZ CONSULTANTS LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 107 107
2015 222 222
2016 210 210
2017 347 347
2018 294 294
2019 415 415
2020 269 269
2021 107 107
2022 99 99
2023 49 49
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 520 520
Adverse Event Without Identified Device or Use Problem 360 360
Loss of Osseointegration 239 239
Device-Device Incompatibility 204 204
Appropriate Term/Code Not Available 187 187
Device Dislodged or Dislocated 143 143
Break 130 130
Material Twisted/Bent 113 113
Biocompatibility 103 103
Scratched Material 77 77
Corroded 66 66
Fracture 58 58
Migration or Expulsion of Device 57 57
Fitting Problem 57 57
Naturally Worn 50 50
Loose or Intermittent Connection 48 48
Degraded 36 36
Osseointegration Problem 30 30
Material Deformation 29 29
Nonstandard Device 26 26
Physical Resistance/Sticking 25 25
Inadequacy of Device Shape and/or Size 24 24
Migration 23 23
Detachment Of Device Component 17 17
Device Contaminated During Manufacture or Shipping 17 17
Malposition of Device 17 17
Loss of or Failure to Bond 16 16
Tear, Rip or Hole in Device Packaging 14 14
Device Operates Differently Than Expected 14 14
Packaging Problem 14 14
Material Integrity Problem 12 12
Difficult to Remove 11 11
Metal Shedding Debris 11 11
Mechanical Jam 10 10
Mechanical Problem 10 10
Noise, Audible 10 10
Device Slipped 9 9
Unstable 8 8
Entrapment of Device 8 8
Connection Problem 8 8
Detachment of Device or Device Component 8 8
Patient Device Interaction Problem 8 8
Positioning Problem 8 8
Computer System Security Problem 7 7
Patient-Device Incompatibility 7 7
Defective Device 7 7
Failure to Osseointegrate 7 7
Difficult to Insert 7 7
Crack 6 6
Compatibility Problem 6 6
Device Contamination with Chemical or Other Material 5 5
Material Erosion 5 5
Material Discolored 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Use of Device Problem 4 4
Material Disintegration 3 3
Material Fragmentation 3 3
Failure To Adhere Or Bond 3 3
Manufacturing, Packaging or Shipping Problem 3 3
No Apparent Adverse Event 3 3
Unintended Movement 3 3
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Device Expiration Issue 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
No Device Output 1 1
Overheating of Device 1 1
Vibration 1 1
Stretched 1 1
Device Inoperable 1 1
Incorrect Measurement 1 1
Disassembly 1 1
Microbial Contamination of Device 1 1
Residue After Decontamination 1 1
Device Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Packaging Compromised 1 1
Improper Chemical Reaction 1 1
Mechanics Altered 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 517 517
No Code Available 405 405
No Consequences Or Impact To Patient 400 400
Injury 249 249
Unspecified Infection 236 236
Bone Fracture(s) 184 184
No Information 178 178
Not Applicable 116 116
Metal Related Pathology 113 113
Joint Dislocation 112 112
Insufficient Information 111 111
Inadequate Osseointegration 100 100
Discomfort 89 89
Test Result 79 79
Inflammation 75 75
Foreign Body Reaction 68 68
Osteolysis 64 64
Tissue Damage 62 62
Fall 57 57
No Known Impact Or Consequence To Patient 56 56
Failure of Implant 54 54
Host-Tissue Reaction 47 47
Ambulation Difficulties 44 44
Limited Mobility Of The Implanted Joint 43 43
Reaction 42 42
Loss of Range of Motion 40 40
No Clinical Signs, Symptoms or Conditions 35 35
Necrosis 21 21
Swelling 20 20
Distress 19 19
Hypersensitivity/Allergic reaction 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Infiltration into Tissue 15 15
Edema 15 15
Weakness 15 15
Blood Loss 14 14
Toxicity 13 13
Synovitis 12 12
Leiomyosarcoma 11 11
Arthralgia 9 9
Hip Fracture 8 8
Thrombosis 8 8
Hematoma 8 8
Fatigue 7 7
Anxiety 7 7
Swelling/ Edema 7 7
Cyst(s) 6 6
Arthritis 6 6
Ossification 5 5
Adhesion(s) 5 5
Muscular Rigidity 5 5
Unspecified Tissue Injury 5 5
No Patient Involvement 5 5
Fluid Discharge 5 5
Depression 4 4
Joint Laxity 4 4
Implant Pain 4 4
Myocardial Infarction 4 4
Complaint, Ill-Defined 4 4
Malaise 3 3
Deformity/ Disfigurement 3 3
Scar Tissue 3 3
Muscle Weakness 3 3
Bacterial Infection 3 3
Death 3 3
Solid Tumour 3 3
Foreign Body In Patient 3 3
Osteopenia/ Osteoporosis 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Confusion/ Disorientation 2 2
Numbness 2 2
Limb Fracture 2 2
Muscle/Tendon Damage 2 2
Erosion 2 2
Abscess 2 2
Itching Sensation 2 2
Infarction, Cerebral 2 2
Hemorrhage/Bleeding 2 2
Pocket Erosion 2 2
Nerve Damage 2 2
Scarring 2 2
Thrombus 2 2
Joint Swelling 2 2
Renal Failure 2 2
Heart Failure 1 1
Hypoesthesia 1 1
Tinnitus 1 1
Sepsis 1 1
Seroma 1 1
Pneumonia 1 1
Rash 1 1
Local Reaction 1 1
Hyperplasia 1 1
Headache 1 1
Fistula 1 1
Wound Dehiscence 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Oct-11-2018
2 DePuy Orthopaedics, Inc. II Feb-12-2018
3 Smith & Nephew, Inc. II Jan-05-2016
4 Stryker Howmedica Osteonics Corp. III Sep-14-2009
5 Stryker Howmedica Osteonics Corp. II Jul-22-2009
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