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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
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
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 382 382
2018 335 335
2019 340 340
2020 336 336
2021 373 373
2022 211 211

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 531 531
Adverse Event Without Identified Device or Use Problem 306 306
Device Dislodged or Dislocated 238 238
Device-Device Incompatibility 198 198
Appropriate Term/Code Not Available 163 163
Break 125 125
Fracture 87 87
Loose or Intermittent Connection 56 56
Corroded 50 50
Osseointegration Problem 45 45
Degraded 41 41
Loss of Osseointegration 36 36
Malposition of Device 27 27
Detachment of Device or Device Component 27 27
Naturally Worn 27 27
Material Erosion 26 26
Material Deformation 25 25
Unstable 24 24
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Migration 24 24
Mechanical Problem 20 20
Migration or Expulsion of Device 19 19
Inadequacy of Device Shape and/or Size 18 18
Noise, Audible 13 13
Device Contaminated During Manufacture or Shipping 12 12
Tear, Rip or Hole in Device Packaging 12 12
Patient-Device Incompatibility 11 11
Metal Shedding Debris 10 10
Positioning Problem 9 9
Unintended Movement 8 8
Difficult to Remove 8 8
Device Slipped 7 7
Microbial Contamination of Device 7 7
Failure to Cut 7 7
Device Operates Differently Than Expected 7 7
Material Fragmentation 5 5
Difficult to Insert 5 5
Contamination 4 4
Off-Label Use 4 4
Nonstandard Device 4 4
Material Integrity Problem 4 4
Compatibility Problem 4 4
Inaccurate Information 4 4
Mechanical Jam 3 3
Packaging Problem 3 3
Scratched Material 3 3
Patient Device Interaction Problem 3 3
Material Protrusion/Extrusion 3 3
Device Contamination with Chemical or Other Material 3 3
Device Markings/Labelling Problem 3 3
Defective Device 3 3
Component Missing 3 3
Deformation Due to Compressive Stress 2 2
Calibration Problem 2 2
Connection Problem 2 2
Device Packaging Compromised 2 2
Material Separation 2 2
Material Discolored 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 1 1
Separation Problem 1 1
Difficult or Delayed Separation 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
Device Appears to Trigger Rejection 1 1
Use of Device Problem 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Difficult To Position 1 1
Misconnection 1 1
Device Damaged by Another Device 1 1
Device Disinfection Or Sterilization Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Data Back-Up Problem 1 1
Delamination 1 1
Device Issue 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Failure to Align 1 1
Dent in Material 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 584 584
Pain 384 384
Unspecified Infection 298 298
Inflammation 230 230
Reaction 210 210
Joint Dislocation 178 178
Foreign Body Reaction 98 98
No Clinical Signs, Symptoms or Conditions 89 89
Failure of Implant 88 88
Bone Fracture(s) 86 86
Inadequate Osseointegration 78 78
Insufficient Information 76 76
Ambulation Difficulties 66 66
No Information 66 66
Fall 60 60
No Known Impact Or Consequence To Patient 59 59
Metal Related Pathology 58 58
No Code Available 57 57
No Consequences Or Impact To Patient 53 53
Osteolysis 49 49
Joint Disorder 42 42
Discomfort 33 33
Limb Fracture 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
No Patient Involvement 22 22
Hip Fracture 22 22
Joint Laxity 16 16
Tissue Damage 15 15
Bacterial Infection 15 15
Local Reaction 14 14
Necrosis 13 13
Hematoma 12 12
Limited Mobility Of The Implanted Joint 12 12
Loss of Range of Motion 11 11
Swelling/ Edema 9 9
Muscle/Tendon Damage 8 8
Host-Tissue Reaction 7 7
Edema 7 7
Cyst(s) 7 7
Ossification 6 6
Weakness 5 5
Unequal Limb Length 5 5
Device Embedded In Tissue or Plaque 5 5
Foreign Body In Patient 5 5
Patient Problem/Medical Problem 5 5
Implant Pain 5 5
Unspecified Tissue Injury 4 4
Fluid Discharge 4 4
Swelling 4 4
Synovitis 4 4
Deformity/ Disfigurement 4 4
Depression 4 4
Abscess 4 4
Wound Dehiscence 4 4
Erythema 3 3
Fatigue 3 3
Erosion 3 3
Calcium Deposits/Calcification 3 3
Hypersensitivity/Allergic reaction 3 3
Peroneal Nerve Palsy 3 3
Toxicity 3 3
Seroma 3 3
Impaired Healing 3 3
Not Applicable 3 3
Heart Failure/Congestive Heart Failure 3 3
Test Result 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Weight Changes 2 2
Osteopenia/ Osteoporosis 2 2
Physical Asymmetry 2 2
Scar Tissue 2 2
Sepsis 2 2
Muscular Rigidity 2 2
Complaint, Ill-Defined 2 2
Numbness 2 2
Reaction, Injection Site 2 2
Hemorrhage/Bleeding 2 2
Granuloma 2 2
Cellulitis 2 2
Purulent Discharge 2 2
Flashers 1 1
Cardiomyopathy 1 1
Adhesion(s) 1 1
Anemia 1 1
Arthritis 1 1
Headache 1 1
Hyperplasia 1 1
Necrosis Of Flap Tissue 1 1
Nerve Damage 1 1
Neurological Deficit/Dysfunction 1 1
Irritation 1 1
Muscle Weakness 1 1
Sweating 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Arthralgia 1 1
Joint Swelling 1 1
Skin Discoloration 1 1
Tachycardia 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 Smith & Nephew, Inc. II Jan-04-2017
11 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
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