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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, uncemented, metal / polymer, non-porous, calcium phosphate
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 335 335
2019 340 340
2020 336 336
2021 373 373
2022 322 322
2023 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 391 391
Adverse Event Without Identified Device or Use Problem 359 359
Device-Device Incompatibility 217 217
Device Dislodged or Dislocated 196 196
Appropriate Term/Code Not Available 157 157
Break 111 111
Fracture 66 66
Osseointegration Problem 54 54
Loose or Intermittent Connection 47 47
Degraded 39 39
Detachment of Device or Device Component 33 33
Material Erosion 31 31
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Corroded 26 26
Migration 25 25
Unstable 23 23
Loss of Osseointegration 22 22
Malposition of Device 22 22
Naturally Worn 16 16
Device Contaminated During Manufacture or Shipping 15 15
Tear, Rip or Hole in Device Packaging 14 14
Material Deformation 14 14
Noise, Audible 11 11
Inadequacy of Device Shape and/or Size 11 11
Mechanical Problem 10 10
Migration or Expulsion of Device 9 9
Device Appears to Trigger Rejection 8 8
Patient-Device Incompatibility 8 8
Failure to Cut 7 7
Positioning Problem 6 6
Unintended Movement 5 5
Difficult to Insert 5 5
Microbial Contamination of Device 5 5
Inaccurate Information 5 5
Off-Label Use 4 4
Difficult to Remove 4 4
Material Fragmentation 4 4
Defective Device 4 4
Device Contamination with Chemical or Other Material 3 3
Compatibility Problem 3 3
Device Markings/Labelling Problem 3 3
Patient Device Interaction Problem 3 3
Material Integrity Problem 3 3
Component Missing 3 3
Use of Device Problem 3 3
Metal Shedding Debris 2 2
Device Slipped 2 2
Nonstandard Device 2 2
Mechanical Jam 2 2
Packaging Problem 2 2
Deformation Due to Compressive Stress 2 2
Calibration Problem 2 2
Connection Problem 1 1
Data Back-Up Problem 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Failure to Osseointegrate 1 1
Fitting Problem 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
Dent in Material 1 1
Loss of or Failure to Bond 1 1
Misconnection 1 1
Crack 1 1
Collapse 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Wrong Label 1 1
Separation Problem 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 401 401
Pain 308 308
Unspecified Infection 290 290
Inflammation 196 196
Joint Dislocation 165 165
Reaction 156 156
Foreign Body Reaction 104 104
No Clinical Signs, Symptoms or Conditions 100 100
Insufficient Information 87 87
Metal Related Pathology 78 78
Inadequate Osseointegration 74 74
Failure of Implant 70 70
Bone Fracture(s) 67 67
Ambulation Difficulties 62 62
Fall 56 56
No Known Impact Or Consequence To Patient 50 50
Limb Fracture 49 49
No Consequences Or Impact To Patient 49 49
No Code Available 34 34
Osteolysis 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
No Information 26 26
Joint Disorder 25 25
Joint Laxity 23 23
No Patient Involvement 22 22
Discomfort 14 14
Hip Fracture 14 14
Bacterial Infection 14 14
Local Reaction 14 14
Necrosis 10 10
Hematoma 10 10
Loss of Range of Motion 8 8
Tissue Damage 8 8
Muscle/Tendon Damage 8 8
Swelling/ Edema 8 8
Limited Mobility Of The Implanted Joint 7 7
Implant Pain 6 6
Physical Asymmetry 6 6
Host-Tissue Reaction 6 6
Ossification 5 5
Patient Problem/Medical Problem 5 5
Unequal Limb Length 5 5
Fluid Discharge 4 4
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 4 4
Unspecified Tissue Injury 4 4
Abscess 4 4
Wound Dehiscence 4 4
Deformity/ Disfigurement 4 4
Depression 4 4
Weakness 3 3
Synovitis 3 3
Toxicity 3 3
Numbness 3 3
Post Operative Wound Infection 3 3
Osteopenia/ Osteoporosis 3 3
Calcium Deposits/Calcification 3 3
Cyst(s) 3 3
Erythema 3 3
Nerve Damage 3 3
Heart Failure/Congestive Heart Failure 3 3
Not Applicable 2 2
Scar Tissue 2 2
Sepsis 2 2
Seroma 2 2
Hypersensitivity/Allergic reaction 2 2
Hemorrhage/Bleeding 2 2
Muscular Rigidity 2 2
Purulent Discharge 2 2
Granuloma 2 2
Cellulitis 2 2
Erosion 2 2
Blood Loss 2 2
Reaction, Injection Site 2 2
Impaired Healing 2 2
Sweating 1 1
Weight Changes 1 1
Confusion/ Disorientation 1 1
Tachycardia 1 1
Burning Sensation 1 1
Loss of Vision 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Rupture 1 1
Discharge 1 1
Excessive Tear Production 1 1
Distress 1 1
Cardiomyopathy 1 1
Headache 1 1
Edema 1 1
Fatigue 1 1
Flashers 1 1
Irritation 1 1
Hyperplasia 1 1
Skin Discoloration 1 1
Swelling 1 1
Neurological Deficit/Dysfunction 1 1
Necrosis Of Flap Tissue 1 1
Test Result 1 1
Pericarditis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Corin Ltd II Sep-30-2021
3 Corin Ltd II Jun-11-2021
4 Corin Ltd II Mar-22-2021
5 Exactech, Inc. II Sep-09-2022
6 Exactech, Inc. II Jan-18-2018
7 Signature Orthopaedics Europe Ltd II Mar-25-2020
8 Signature Orthopedics Pty Limited II May-28-2021
9 Signature Orthopedics Pty Limited II Mar-06-2018
10 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
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