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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 2
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  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
2016 347 347
2017 381 381
2018 335 335
2019 340 340
2020 336 336
2021 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 649 649
Device Dislodged or Dislocated 257 257
Adverse Event Without Identified Device or Use Problem 224 224
Appropriate Term/Code Not Available 144 144
Break 131 131
Device-Device Incompatibility 112 112
Fracture 95 95
Loose or Intermittent Connection 61 61
Corroded 56 56
Degraded 48 48
Naturally Worn 44 44
Loss of Osseointegration 40 40
Malposition of Device 36 36
Osseointegration Problem 33 33
Mechanical Problem 32 32
Migration or Expulsion of Device 30 30
Material Deformation 29 29
Unstable 25 25
Material Erosion 24 24
Migration 22 22
Inadequacy of Device Shape and/or Size 19 19
Metal Shedding Debris 19 19
Detachment of Device or Device Component 18 18
Material Integrity Problem 18 18
Positioning Problem 18 18
Loosening of Implant Not Related to Bone-Ingrowth 17 17
Device Operates Differently Than Expected 15 15
Patient-Device Incompatibility 13 13
Noise, Audible 13 13
Device Slipped 12 12
Device Contaminated During Manufacture or Shipping 9 9
Unintended Movement 9 9
Failure To Adhere Or Bond 9 9
Tear, Rip or Hole in Device Packaging 8 8
Difficult to Remove 8 8
Microbial Contamination of Device 7 7
Failure to Cut 7 7
Compatibility Problem 7 7
Scratched Material 6 6
Detachment Of Device Component 5 5
Off-Label Use 5 5
Material Fragmentation 5 5
Nonstandard Device 4 4
Material Protrusion/Extrusion 4 4
Inaccurate Information 4 4
Contamination 4 4
Device Contamination with Chemical or Other Material 4 4
Device Markings/Labelling Problem 3 3
Connection Problem 3 3
Difficult to Insert 3 3
Packaging Problem 3 3
Device Packaging Compromised 3 3
Mechanical Jam 3 3
Component Missing 3 3
Use of Device Problem 2 2
Defective Device 2 2
Device Damaged by Another Device 2 2
Calibration Problem 2 2
Material Separation 2 2
Disassembly 2 2
Patient Device Interaction Problem 2 2
Material Discolored 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 1 1
Improper or Incorrect Procedure or Method 1 1
Biological Environmental Factor 1 1
Dent in Material 1 1
Device Displays Incorrect Message 1 1
Data Back-Up Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Extrusion 1 1
Disconnection 1 1
Difficult or Delayed Positioning 1 1
Partial Blockage 1 1
Leak/Splash 1 1
Sticking 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Difficult or Delayed Separation 1 1
Device Expiration Issue 1 1
Unintended Head Motion 1 1
Positioning Failure 1 1
Collapse 1 1
Crack 1 1
Loss of or Failure to Bond 1 1
Difficult To Position 1 1
Delamination 1 1
Deformation Due to Compressive Stress 1 1
Failure to Osseointegrate 1 1
Device Issue 1 1
Failure to Align 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 687 687
Pain 390 390
Unspecified Infection 266 266
Reaction 230 230
Inflammation 229 229
Joint Dislocation 204 204
No Code Available 114 114
No Information 113 113
Bone Fracture(s) 87 87
No Known Impact Or Consequence To Patient 75 75
Failure of Implant 74 74
No Clinical Signs, Symptoms or Conditions 68 68
Inadequate Osseointegration 67 67
No Consequences Or Impact To Patient 64 64
Ambulation Difficulties 57 57
Fall 55 55
Joint Disorder 47 47
Osteolysis 45 45
Foreign Body Reaction 44 44
No Patient Involvement 37 37
Insufficient Information 37 37
Discomfort 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Metal Related Pathology 19 19
Hip Fracture 17 17
Tissue Damage 17 17
Limb Fracture 14 14
Local Reaction 13 13
Bacterial Infection 12 12
Edema 11 11
Limited Mobility Of The Implanted Joint 11 11
Hematoma 11 11
Swelling 11 11
Loss of Range of Motion 9 9
Toxicity 9 9
Cyst(s) 8 8
Necrosis 8 8
Host-Tissue Reaction 7 7
Patient Problem/Medical Problem 6 6
Joint Laxity 6 6
Weakness 6 6
Ossification 5 5
Device Embedded In Tissue or Plaque 5 5
Foreign Body In Patient 4 4
Scar Tissue 4 4
Complaint, Ill-Defined 4 4
Depression 4 4
Staphylococcus Aureus 4 4
Muscle/Tendon Damage 4 4
Fluid Discharge 3 3
Peroneal Nerve Palsy 3 3
Post Operative Wound Infection 3 3
Granuloma 3 3
Not Applicable 3 3
Test Result 3 3
Implant Pain 3 3
Erosion 3 3
Calcium Deposits/Calcification 3 3
Fatigue 2 2
Unequal Limb Length 2 2
Hemorrhage/Bleeding 2 2
Synovitis 2 2
Blood Loss 2 2
Weight Changes 2 2
Impaired Healing 2 2
Discharge 2 2
Osteopenia/ Osteoporosis 2 2
Numbness 2 2
Reaction, Injection Site 2 2
Sweating 1 1
Excessive Tear Production 1 1
Sepsis 1 1
Skin Discoloration 1 1
Physical Asymmetry 1 1
Cancer 1 1
Pericarditis 1 1
Disability 1 1
Arthralgia 1 1
Joint Swelling 1 1
Burning Sensation 1 1
Tachycardia 1 1
Seroma 1 1
Death 1 1
Necrosis Of Flap Tissue 1 1
Nerve Damage 1 1
Localized Skin Lesion 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Wound Dehiscence 1 1
Missing Value Reason 1 1
Tissue Breakdown 1 1
Hyperplasia 1 1
Hypersensitivity/Allergic reaction 1 1
Irritation 1 1
Muscle Weakness 1 1
Neurological Deficit/Dysfunction 1 1
Cardiomyopathy 1 1
Erythema 1 1
Abscess 1 1
Anemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Corin Ltd II Jun-11-2021
3 Corin Ltd II Mar-22-2021
4 Depuy Orthopaedics Inc. II Nov-21-2016
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 Smith & Nephew, Inc. II Jul-28-2016
11 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
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