• 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, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OVERTURE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OVERTURE RESURFACING INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 273 273
2021 240 240
2022 258 258
2023 231 231
2024 172 172
2025 71 154

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 418 501
Fracture 192 248
Break 130 130
Loosening of Implant Not Related to Bone-Ingrowth 102 129
Appropriate Term/Code Not Available 66 66
Migration 32 32
Crack 26 26
Device Dislodged or Dislocated 25 25
Naturally Worn 22 22
Mechanical Jam 21 21
Device Appears to Trigger Rejection 20 20
Flaked 19 19
Unstable 18 18
Material Fragmentation 17 17
Connection Problem 16 16
Malposition of Device 15 15
Loss of Osseointegration 15 15
Difficult to Insert 15 15
Positioning Failure 14 14
Insufficient Information 13 13
Fitting Problem 12 12
Loose or Intermittent Connection 10 10
Loss of or Failure to Bond 10 10
Material Deformation 9 9
Failure to Osseointegrate 8 8
Noise, Audible 7 7
Material Twisted/Bent 7 7
Corroded 7 7
Degraded 7 7
Material Erosion 7 23
Device Damaged by Another Device 6 6
Material Protrusion/Extrusion 6 6
Defective Device 6 6
Detachment of Device or Device Component 5 5
Patient Device Interaction Problem 5 5
Separation Failure 5 5
Osseointegration Problem 4 60
Manufacturing, Packaging or Shipping Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Packaging Problem 3 3
Incomplete or Inadequate Connection 3 3
Migration or Expulsion of Device 3 3
Peeled/Delaminated 3 3
Use of Device Problem 3 3
Biocompatibility 2 2
Expiration Date Error 2 2
Microbial Contamination of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Material Separation 2 2
Unsealed Device Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 314 314
Pain 296 352
Failure of Implant 121 121
Unspecified Infection 109 176
Insufficient Information 94 177
Bone Fracture(s) 68 68
No Known Impact Or Consequence To Patient 58 58
Inadequate Osseointegration 52 52
Joint Laxity 40 112
Swelling/ Edema 32 32
Loss of Range of Motion 28 28
Joint Dislocation 28 28
Device Embedded In Tissue or Plaque 25 25
Foreign Body In Patient 25 25
No Information 24 24
Implant Pain 21 21
Arthralgia 21 37
Swelling 19 19
Fall 18 18
No Patient Involvement 18 18
Arthritis 16 32
No Consequences Or Impact To Patient 16 16
Ambulation Difficulties 15 15
Osteolysis 15 31
Injury 15 15
Inflammation 12 12
Metal Related Pathology 11 11
Discomfort 10 10
Limited Mobility Of The Implanted Joint 9 9
Synovitis 9 9
No Code Available 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Numbness 8 8
Osteopenia/ Osteoporosis 7 7
Reaction 5 5
Damage to Ligament(s) 5 5
Cyst(s) 4 4
Joint Disorder 4 4
Unspecified Tissue Injury 4 4
Hematoma 3 59
Deformity/ Disfigurement 3 3
Joint Swelling 3 3
Patient Problem/Medical Problem 3 3
Scar Tissue 3 3
Embolism/Embolus 3 3
Hemorrhage/Bleeding 2 2
Erosion 2 2
Adhesion(s) 2 2
Wound Dehiscence 2 2
Necrosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, LP II Nov-20-2020
2 Howmedica Osteonics Corp. II Apr-12-2023
3 Linkbio Corp. II May-04-2023
4 Smith & Nephew, Inc. II May-31-2023
5 Smith & Nephew, Inc. II Apr-14-2023
6 Smith & Nephew, Inc. II May-27-2020
-
-