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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
2014 146 146
2015 394 394
2016 384 384
2017 328 328
2018 451 451
2019 335 335
2020 1046 1046
2021 1206 1206
2022 886 886
2023 289 289
2024 87 87

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1732 1732
Insufficient Information 977 977
Fracture 562 562
Adverse Event Without Identified Device or Use Problem 412 412
Device Dislodged or Dislocated 219 219
Material Twisted/Bent 211 211
Crack 193 193
Appropriate Term/Code Not Available 182 182
Material Deformation 167 167
Naturally Worn 153 153
Connection Problem 98 98
Loss of Osseointegration 92 92
Corroded 78 78
Defective Device 73 73
Detachment of Device or Device Component 65 65
Material Fragmentation 65 65
Loose or Intermittent Connection 64 64
Mechanical Problem 53 53
Unstable 46 46
Incomplete or Inadequate Connection 41 41
Migration or Expulsion of Device 38 38
Dull, Blunt 38 38
Mechanics Altered 37 37
Biocompatibility 37 37
Noise, Audible 36 36
Mechanical Jam 30 30
Malposition of Device 29 29
Degraded 29 29
Material Erosion 28 28
Flaked 26 26
Metal Shedding Debris 25 25
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Loss of or Failure to Bond 19 19
Material Separation 18 18
Migration 18 18
Physical Resistance/Sticking 18 18
Scratched Material 17 17
Peeled/Delaminated 16 16
Material Disintegration 15 15
Component Missing 15 15
Device Slipped 14 14
Nonstandard Device 10 10
Inadequacy of Device Shape and/or Size 9 9
Deformation Due to Compressive Stress 8 8
Material Integrity Problem 8 8
Activation, Positioning or Separation Problem 8 8
Premature Separation 8 8
Positioning Problem 7 7
Failure to Align 7 7
Solder Joint Fracture 6 6
Osseointegration Problem 6 6
Difficult or Delayed Separation 6 6
Separation Failure 5 5
Difficult to Insert 5 5
Failure To Adhere Or Bond 5 5
Positioning Failure 5 5
Off-Label Use 4 4
Patient-Device Incompatibility 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Misconnection 4 4
Unintended Movement 4 4
No Apparent Adverse Event 4 4
Sharp Edges 4 4
Material Split, Cut or Torn 4 4
Patient Device Interaction Problem 4 4
Device Handling Problem 3 3
Failure to Clean Adequately 3 3
Improper or Incorrect Procedure or Method 3 3
Difficult to Remove 3 3
Problem with Sterilization 3 3
Use of Device Problem 3 3
Device Appears to Trigger Rejection 2 2
Delivered as Unsterile Product 2 2
Component Incompatible 2 2
Material Discolored 2 2
Failure to Osseointegrate 2 2
Incomplete Coaptation 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Compatibility Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unclear Information 2 2
Device Fell 2 2
Therapeutic or Diagnostic Output Failure 1 1
Activation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Tear, Rip or Hole in Device Packaging 1 1
Disconnection 1 1
Contamination 1 1
Disassembly 1 1
Misassembled 1 1
Unraveled Material 1 1
Failure to Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2509 2509
Pain 718 718
No Information 454 454
No Code Available 388 388
No Known Impact Or Consequence To Patient 379 379
Injury 267 267
No Patient Involvement 238 238
No Consequences Or Impact To Patient 217 217
Unspecified Infection 193 193
Joint Dislocation 179 179
Host-Tissue Reaction 136 136
Inflammation 117 117
Discomfort 115 115
Bone Fracture(s) 105 105
Failure of Implant 100 100
Foreign Body Reaction 95 95
Osteolysis 85 85
Tissue Damage 81 81
Reaction 80 80
Test Result 68 68
Not Applicable 63 63
Insufficient Information 59 59
Inadequate Osseointegration 51 51
Limited Mobility Of The Implanted Joint 41 41
Metal Related Pathology 37 37
Loss of Range of Motion 37 37
Foreign Body In Patient 27 27
Ambulation Difficulties 25 25
Swelling 25 25
Fall 23 23
Toxicity 22 22
Deformity/ Disfigurement 18 18
Hip Fracture 14 14
Bacterial Infection 12 12
Hypersensitivity/Allergic reaction 11 11
Death 10 10
Thrombosis/Thrombus 10 10
Impaired Healing 9 9
Blood Loss 9 9
Necrosis 9 9
Synovitis 8 8
Distress 8 8
Device Embedded In Tissue or Plaque 8 8
Nerve Damage 7 7
Local Reaction 7 7
Edema 7 7
Ossification 7 7
Cyst(s) 7 7
Fatigue 6 6
Hematoma 6 6
Thrombosis 6 6
Swelling/ Edema 6 6
Subluxation 6 6
Post Operative Wound Infection 6 6
Joint Swelling 6 6
Joint Disorder 5 5
Depression 5 5
Non-union Bone Fracture 5 5
Perforation 5 5
Weakness 5 5
Scar Tissue 5 5
Muscular Rigidity 5 5
Wound Dehiscence 5 5
Scarring 4 4
Confusion/ Disorientation 4 4
Osteopenia/ Osteoporosis 4 4
Unspecified Tissue Injury 4 4
Joint Laxity 3 3
Malunion of Bone 3 3
Fluid Discharge 3 3
Muscle/Tendon Damage 3 3
Peroneal Nerve Palsy 3 3
Complaint, Ill-Defined 3 3
Muscle Weakness 3 3
Cellulitis 3 3
Irritation 3 3
Hemorrhage/Bleeding 2 2
Granuloma 2 2
Infarction, Cerebral 2 2
Embolism 2 2
Arthritis 2 2
Pulmonary Embolism 2 2
Nausea 2 2
Dizziness 2 2
Urinary Tract Infection 2 2
Disability 2 2
Patient Problem/Medical Problem 2 2
Unequal Limb Length 2 2
Balance Problems 2 2
Implant Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Movement Disorder 1 1
Limb Fracture 1 1
Unspecified Musculoskeletal problem 1 1
Solid Tumour 1 1
Cancer 1 1
Fibrosis 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1
Numbness 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 Stryker Howmedica Osteonics Corp. II Nov-23-2009
4 Waldemar Link GmbH & Co. KG (Mfg Site) II Mar-14-2024
5 Zimmer, Inc. II Aug-26-2014
6 Zimmer, Inc. II Aug-13-2014
7 Zimmer, Inc. II Feb-20-2014
8 Zimmer, Inc. II Aug-17-2013
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