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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
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 381 381
2018 335 335
2019 340 340
2020 336 336
2021 370 370

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 511 511
Adverse Event Without Identified Device or Use Problem 230 230
Device Dislodged or Dislocated 224 224
Device-Device Incompatibility 143 143
Appropriate Term/Code Not Available 131 131
Break 123 123
Fracture 80 80
Loose or Intermittent Connection 54 54
Corroded 49 49
Degraded 35 35
Loss of Osseointegration 34 34
Osseointegration Problem 34 34
Malposition of Device 26 26
Material Deformation 24 24
Naturally Worn 24 24
Material Erosion 23 23
Migration 21 21
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Mechanical Problem 20 20
Detachment of Device or Device Component 20 20
Unstable 20 20
Migration or Expulsion of Device 19 19
Inadequacy of Device Shape and/or Size 18 18
Noise, Audible 12 12
Patient-Device Incompatibility 11 11
Metal Shedding Debris 10 10
Device Contaminated During Manufacture or Shipping 10 10
Positioning Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Difficult to Remove 8 8
Unintended Movement 8 8
Device Slipped 7 7
Failure to Cut 7 7
Microbial Contamination of Device 7 7
Device Operates Differently Than Expected 7 7
Material Fragmentation 5 5
Difficult to Insert 4 4
Contamination 4 4
Nonstandard Device 4 4
Compatibility Problem 4 4
Off-Label Use 4 4
Inaccurate Information 4 4
Scratched Material 3 3
Packaging Problem 3 3
Mechanical Jam 3 3
Component Missing 3 3
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Device Markings/Labelling Problem 3 3
Device Packaging Compromised 2 2
Defective Device 2 2
Calibration Problem 2 2
Connection Problem 2 2
Material Separation 2 2
Material Discolored 2 2
No Apparent Adverse Event 2 2
Difficult or Delayed Separation 1 1
Patient Device Interaction Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Entrapment of Device 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Disassembly 1 1
Collapse 1 1
Failure To Adhere Or Bond 1 1
Loss of or Failure to Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Difficult To Position 1 1
Misconnection 1 1
Data Back-Up Problem 1 1
Delamination 1 1
Device Issue 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Dent in Material 1 1
Separation Failure 1 1
Device Damaged by Another Device 1 1
Deformation Due to Compressive Stress 1 1
Device Disinfection Or Sterilization Issue 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 584 584
Pain 339 339
Unspecified Infection 236 236
Inflammation 227 227
Reaction 210 210
Joint Dislocation 168 168
Failure of Implant 80 80
No Clinical Signs, Symptoms or Conditions 78 78
Bone Fracture(s) 77 77
No Information 66 66
Inadequate Osseointegration 65 65
Foreign Body Reaction 61 61
No Known Impact Or Consequence To Patient 59 59
Ambulation Difficulties 58 58
No Code Available 57 57
No Consequences Or Impact To Patient 53 53
Fall 51 51
Insufficient Information 48 48
Osteolysis 43 43
Joint Disorder 42 42
Discomfort 33 33
Metal Related Pathology 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
No Patient Involvement 22 22
Limb Fracture 20 20
Hip Fracture 19 19
Tissue Damage 15 15
Bacterial Infection 15 15
Local Reaction 14 14
Necrosis 11 11
Hematoma 11 11
Limited Mobility Of The Implanted Joint 11 11
Joint Laxity 10 10
Muscle/Tendon Damage 8 8
Host-Tissue Reaction 7 7
Edema 7 7
Cyst(s) 7 7
Ossification 6 6
Loss of Range of Motion 6 6
Weakness 5 5
Patient Problem/Medical Problem 5 5
Swelling/ Edema 5 5
Device Embedded In Tissue or Plaque 5 5
Unequal Limb Length 4 4
Foreign Body In Patient 4 4
Swelling 4 4
Depression 4 4
Abscess 4 4
Erosion 3 3
Calcium Deposits/Calcification 3 3
Peroneal Nerve Palsy 3 3
Toxicity 3 3
Synovitis 3 3
Seroma 3 3
Fluid Discharge 3 3
Unspecified Tissue Injury 3 3
Implant Pain 3 3
Not Applicable 3 3
Physical Asymmetry 2 2
Test Result 2 2
Osteopenia/ Osteoporosis 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Weight Changes 2 2
Impaired Healing 2 2
Scar Tissue 2 2
Sepsis 2 2
Complaint, Ill-Defined 2 2
Deformity/ Disfigurement 2 2
Numbness 2 2
Reaction, Injection Site 2 2
Purulent Discharge 2 2
Wound Dehiscence 2 2
Cellulitis 2 2
Erythema 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
Hemorrhage/Bleeding 2 2
Granuloma 2 2
Headache 1 1
Hyperplasia 1 1
Irritation 1 1
Muscle Weakness 1 1
Necrosis Of Flap Tissue 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Flashers 1 1
Cardiomyopathy 1 1
Anemia 1 1
Arthritis 1 1
Sweating 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Arthralgia 1 1
Joint Swelling 1 1
Burning Sensation 1 1
Rupture 1 1
Discharge 1 1
Excessive Tear Production 1 1
Skin Discoloration 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 Jan-18-2018
6 Signature Orthopaedics Europe Ltd II Mar-25-2020
7 Signature Orthopedics Pty Limited II May-28-2021
8 Signature Orthopedics Pty Limited II Mar-06-2018
9 Smith & Nephew, Inc. II Jan-04-2017
10 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
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