Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Product CodeMBH
Regulation Number 888.3565
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. DBA DJO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LIMA CORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDISURGE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTIMOTION IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNAL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2021 1539 1547
2022 1261 1281
2023 1263 1295
2024 1497 1513
2025 1576 2411
2026 812 823

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3468 4338
Fracture 1071 1821
Unstable 691 698
Loosening of Implant Not Related to Bone-Ingrowth 314 331
Insufficient Device Problem Information 286 289
Loss of Osseointegration 267 267
Detachment of Device or Device Component 244 248
Break 235 235
Difficult to Insert 200 201
Osseointegration Problem 197 968
Naturally Worn 134 136
Migration 134 137
Degraded 118 118
Device Dislodged or Dislocated 117 119
Mechanical Problem 111 113
Positioning Failure 98 98
Malposition of Device 92 816
Loss of or Failure to Bond 66 69
Noise, Audible 66 67
Use of Device Problem 65 66
Patient Device Interaction Problem 54 57
Material Erosion 53 788
Material Deformation 53 53
Unintended Movement 46 46
Connection Problem 40 40
Loose or Intermittent Connection 38 38
Device Contaminated During Manufacture or Shipping 32 32
Inadequacy of Device Shape and/or Size 27 27
Crack 26 26
Packaging Problem 25 25
Tear, Rip or Hole in Device Packaging 23 23
Failure to Osseointegrate 21 21
Component Missing 19 19
Mechanical Jam 18 18
Implant subsidence 17 17
Device Damaged Prior to Use 17 17
Material Fragmentation 17 17
Incomplete or Inadequate Connection 16 16
Corroded 15 15
Dull, Blunt 15 15
Improper or Incorrect Procedure or Method 14 14
Off-Label Use 14 15
Delivered as Unsterile Product 11 11
Device Damaged Prior to Receipt by User 11 11
Device-Device Incompatibility 10 10
Material Twisted/Bent 10 10
Contamination /Decontamination Problem 10 10
Fitting Problem 9 9
Appropriate Device Problem Term/Code Not Available 9 10
Defective Device 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1913 1934
Pain 1909 2716
Joint Laxity 974 1755
Unspecified Infection 894 1678
Insufficient Information 795 1582
Loss of Range of Motion 726 854
Ambulation or Postural Difficulties 463 471
Inadequate Osseointegration 439 444
Swelling/ Edema 412 414
Failure of Implant 356 374
Scar Tissue 203 203
Bone Fracture(s) 178 180
Fall 170 173
Aseptic loosening 136 915
Adhesion(s) 121 121
Fluid Discharge 103 105
Joint Dislocation 86 811
Muscle/Tendon Damage 67 67
Discomfort 64 65
Inflammation 62 63
Thrombosis/Thrombus 59 59
Muscular Rigidity 56 57
Osteolysis 53 790
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 53 53
Fibrosis 52 52
Hypersensitivity/Allergic reaction 51 53
Damage to Ligament(s) 49 50
Joint effusion 49 50
Arthrofibrosis 47 771
Synovitis 47 773
Unspecified Tissue Injury 45 46
Metal Related Pathology 40 764
Numbness 34 34
Implant Pain 30 30
Wound Dehiscence 26 27
Impaired Healing 25 25
Hematoma 25 26
Medical device site infection 24 24
Bacterial Infection 24 24
Pulmonary Embolism 22 22
Erythema 22 22
Foreign Body Reaction 22 23
Cyst(s) 22 23
Crepitus 21 21
Hemorrhage/Blood Loss/Bleeding 20 20
Subluxation 20 21
Nerve Damage 19 20
Limb Fracture 19 19
Tendinopathy 19 19
Necrosis 18 19

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-22-2024
2 DePuy Orthopaedics, Inc. II Mar-29-2024
3 Encore Medical, LP II Dec-07-2023
4 Encore Medical, LP II Nov-07-2023
5 Encore Medical, LP II Apr-12-2023
6 Howmedica Osteonics Corp. II Jun-17-2026
7 Howmedica Osteonics Corp. II Mar-06-2024
8 Howmedica Osteonics Corp. II May-30-2023
9 Howmedica Osteonics Corp. II Mar-08-2021
10 MicroPort Orthopedics Inc. II Dec-18-2024
11 Zimmer, Inc. II Jun-24-2026
-
-