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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. DBA DJO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTIMOTION IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
SIGNAL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1394 1394
2020 1089 1089
2021 1539 1539
2022 1260 1260
2023 1267 1267
2024 531 531

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2112 2112
Unstable 917 917
Insufficient Information 871 871
Fracture 843 843
Break 459 459
Loss of Osseointegration 302 302
Osseointegration Problem 213 213
Loosening of Implant Not Related to Bone-Ingrowth 178 178
Naturally Worn 176 176
Difficult to Insert 161 161
Detachment of Device or Device Component 154 154
Migration 113 113
Device Dislodged or Dislocated 112 112
Noise, Audible 110 110
Degraded 89 89
Malposition of Device 80 80
Loose or Intermittent Connection 57 57
Unintended Movement 55 55
Connection Problem 52 52
Material Erosion 51 51
Positioning Failure 50 50
Mechanical Problem 49 49
Material Deformation 48 48
Patient Device Interaction Problem 46 46
Appropriate Term/Code Not Available 44 44
Use of Device Problem 44 44
Loss of or Failure to Bond 40 40
Component Missing 36 36
Inadequacy of Device Shape and/or Size 35 35
Crack 35 35
Packaging Problem 32 32
Dull, Blunt 29 29
Mechanical Jam 21 21
Migration or Expulsion of Device 19 19
Failure to Osseointegrate 19 19
Incomplete or Inadequate Connection 17 17
Corroded 16 16
Device Contaminated During Manufacture or Shipping 15 15
Material Fragmentation 15 15
Device Difficult to Setup or Prepare 14 14
Contamination /Decontamination Problem 12 12
Tear, Rip or Hole in Device Packaging 12 12
Device-Device Incompatibility 12 12
Fitting Problem 11 11
Material Separation 11 11
Off-Label Use 11 11
Material Integrity Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Device Contamination with Chemical or Other Material 10 10
Device Damaged Prior to Use 10 10
Scratched Material 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Device Markings/Labelling Problem 8 8
Defective Device 8 8
Device Reprocessing Problem 8 8
Defective Component 7 7
Device Handling Problem 7 7
Physical Resistance/Sticking 6 6
Positioning Problem 6 6
Material Twisted/Bent 6 6
Pitted 5 5
Material Discolored 5 5
Activation, Positioning or Separation Problem 5 5
Wrong Label 5 5
Dent in Material 4 4
Flaked 4 4
Collapse 4 4
Difficult to Open or Remove Packaging Material 4 4
No Apparent Adverse Event 4 4
Delivered as Unsterile Product 4 4
Product Quality Problem 3 3
Patient-Device Incompatibility 3 3
Separation Failure 3 3
Component Incompatible 3 3
Inaccurate Information 2 2
Peeled/Delaminated 2 2
Device Slipped 2 2
Sharp Edges 2 2
Difficult to Remove 2 2
Expiration Date Error 2 2
Misassembled 2 2
Component Misassembled 2 2
Incorrect Measurement 2 2
Deformation Due to Compressive Stress 1 1
Shipping Damage or Problem 1 1
Difficult or Delayed Separation 1 1
Misassembled During Installation 1 1
Problem with Sterilization 1 1
Decoupling 1 1
Compatibility Problem 1 1
Device Fell 1 1
Misconnection 1 1
Entrapment of Device 1 1
Biocompatibility 1 1
Premature Separation 1 1
Moisture Damage 1 1
Separation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Nonstandard Device 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1652 1652
No Clinical Signs, Symptoms or Conditions 1277 1277
Injury 1110 1110
Unspecified Infection 725 725
Joint Laxity 535 535
Loss of Range of Motion 525 525
Inadequate Osseointegration 464 464
Insufficient Information 461 461
Ambulation Difficulties 458 458
No Consequences Or Impact To Patient 259 259
Swelling/ Edema 255 255
Failure of Implant 224 224
No Known Impact Or Consequence To Patient 210 210
Bone Fracture(s) 190 190
Scar Tissue 187 187
Fall 163 163
No Patient Involvement 126 126
Adhesion(s) 115 115
Swelling 111 111
No Information 102 102
Limited Mobility Of The Implanted Joint 82 82
Inflammation 74 74
Muscular Rigidity 73 73
Joint Dislocation 72 72
No Code Available 55 55
Discomfort 54 54
Osteolysis 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 50
Thrombosis/Thrombus 36 36
Fibrosis 33 33
Bacterial Infection 33 33
Synovitis 32 32
Numbness 31 31
Hematoma 31 31
Reaction 31 31
Muscle/Tendon Damage 31 31
Damage to Ligament(s) 30 30
Unspecified Tissue Injury 26 26
Embolism 25 25
Aspiration/Inhalation 24 24
Hypersensitivity/Allergic reaction 23 23
Wound Dehiscence 22 22
Nerve Damage 18 18
Cyst(s) 18 18
Foreign Body Reaction 18 18
Impaired Healing 17 17
Metal Related Pathology 16 16
Rupture 15 15
Limb Fracture 15 15
Tissue Damage 15 15
Implant Pain 15 15
Subluxation 14 14
Embolism/Embolus 14 14
Fluid Discharge 14 14
Necrosis 14 14
Hemorrhage/Bleeding 13 13
Osteopenia/ Osteoporosis 13 13
Arthritis 13 13
Pulmonary Embolism 12 12
Ossification 12 12
Patient Problem/Medical Problem 12 12
Cellulitis 11 11
Deformity/ Disfigurement 10 10
Muscle Weakness 9 9
Burning Sensation 9 9
Thrombosis 9 9
Arthralgia 8 8
Joint Swelling 8 8
Erythema 8 8
Unequal Limb Length 6 6
Increased Sensitivity 6 6
Foreign Body In Patient 5 5
Unspecified Musculoskeletal problem 5 5
Tissue Breakdown 5 5
Peripheral Nervous Injury 5 5
Hyperextension 5 5
Joint Disorder 5 5
Hypoxia 5 5
Joint Contracture 5 5
Erosion 5 5
Bruise/Contusion 4 4
Abscess 4 4
Sepsis 4 4
Anemia 4 4
Ankylosis 4 4
Urinary Retention 3 3
Cardiac Enzyme Elevation 3 3
Nausea 3 3
Skin Burning Sensation 3 3
Rheumatoid Arthritis 3 3
Post Operative Wound Infection 3 3
Weakness 3 3
Laceration(s) 3 3
Neuropathy 3 3
Rash 3 3
Fungal Infection 3 3
Device Embedded In Tissue or Plaque 3 3
Balance Problems 3 3
Edema 3 3
Weight Changes 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-22-2024
2 Biomet, Inc. II Oct-08-2020
3 Biomet, Inc. II May-28-2020
4 DePuy Orthopaedics, Inc. II Mar-29-2024
5 Encore Medical, LP II Dec-07-2023
6 Encore Medical, LP II Nov-07-2023
7 Encore Medical, LP II Apr-12-2023
8 Encore Medical, LP II Oct-07-2020
9 Howmedica Osteonics Corp. II Mar-06-2024
10 Howmedica Osteonics Corp. II May-30-2023
11 Howmedica Osteonics Corp. II Mar-08-2021
12 Howmedica Osteonics Corp. II Sep-27-2019
13 Smith & Nephew, Inc. II Jan-28-2020
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