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, femorotibial, non-constrained, cemented, metal/polymer
Product CodeHSX
Regulation Number 888.3520
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OVERTURE RESURFACING INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 159 159
2019 177 177
2020 273 273
2021 240 240
2022 259 259
2023 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 337 337
Break 151 151
Fracture 140 140
Insufficient Information 105 105
Loosening of Implant Not Related to Bone-Ingrowth 93 93
Appropriate Term/Code Not Available 82 82
Migration 32 32
Loose or Intermittent Connection 30 30
Crack 27 27
Unstable 27 27
Difficult to Insert 21 21
Naturally Worn 20 20
Mechanical Jam 19 19
Malposition of Device 18 18
Connection Problem 16 16
Device Dislodged or Dislocated 16 16
Flaked 15 15
Migration or Expulsion of Device 14 14
Loss of Osseointegration 13 13
Material Fragmentation 13 13
Loss of or Failure to Bond 10 10
Device Appears to Trigger Rejection 10 10
Noise, Audible 10 10
Material Deformation 8 8
Material Twisted/Bent 8 8
Failure to Osseointegrate 7 7
Fitting Problem 7 7
Corroded 7 7
Positioning Failure 7 7
Material Protrusion/Extrusion 6 6
Defective Device 5 5
Degraded 5 5
Mechanical Problem 5 5
Physical Resistance/Sticking 5 5
No Apparent Adverse Event 4 4
Incomplete or Inadequate Connection 4 4
Material Erosion 4 4
Inadequacy of Device Shape and/or Size 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Damaged by Another Device 4 4
Patient Device Interaction Problem 4 4
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Peeled/Delaminated 3 3
Difficult To Position 3 3
Off-Label Use 2 2
Overheating of Device 2 2
Unsealed Device Packaging 2 2
Device Damaged Prior to Use 2 2
Microbial Contamination of Device 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Material Separation 2 2
Expiration Date Error 2 2
Positioning Problem 2 2
Scratched Material 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Activation, Positioning or Separation Problem 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device Contaminated During Manufacture or Shipping 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Cut In Material 1 1
Dent in Material 1 1
Device Slipped 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Incorrect Measurement 1 1
Difficult or Delayed Positioning 1 1
Material Discolored 1 1
Device Reprocessing Problem 1 1
Contamination 1 1
Unintended Application Program Shut Down 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 308 308
No Clinical Signs, Symptoms or Conditions 235 235
Unspecified Infection 121 121
Failure of Implant 107 107
No Known Impact Or Consequence To Patient 85 85
Bone Fracture(s) 84 84
Injury 80 80
Insufficient Information 57 57
No Information 55 55
Inadequate Osseointegration 40 40
No Consequences Or Impact To Patient 37 37
Swelling 36 36
Loss of Range of Motion 32 32
Ambulation Difficulties 25 25
Swelling/ Edema 24 24
Limited Mobility Of The Implanted Joint 22 22
Joint Laxity 21 21
No Code Available 20 20
No Patient Involvement 20 20
Joint Dislocation 19 19
Foreign Body In Patient 18 18
Fall 17 17
Arthralgia 15 15
Osteolysis 15 15
Device Embedded In Tissue or Plaque 13 13
Implant Pain 12 12
Inflammation 12 12
Arthritis 12 12
Discomfort 9 9
Numbness 8 8
Synovitis 8 8
Joint Disorder 7 7
Osteopenia/ Osteoporosis 7 7
Metal Related Pathology 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Patient Problem/Medical Problem 5 5
Reaction 5 5
Unspecified Tissue Injury 4 4
Necrosis 4 4
Joint Swelling 4 4
Cyst(s) 4 4
Wound Dehiscence 3 3
Abscess 3 3
Damage to Ligament(s) 3 3
Embolism/Embolus 3 3
Toxicity 2 2
Muscular Rigidity 2 2
Laceration(s) 2 2
Deformity/ Disfigurement 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Erosion 2 2
Cellulitis 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Ossification 1 1
Bacterial Infection 1 1
Fatigue 1 1
Infiltration into Tissue 1 1
Nerve Damage 1 1
Weakness 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Inadequate Pain Relief 1 1
Post Operative Wound Infection 1 1
Thromboembolism 1 1
Skin Inflammation/ Irritation 1 1

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
7 Zimmer Biomet, Inc. II Mar-28-2018
8 Zimmer Biomet, Inc. II Mar-14-2018
9 Zimmer Biomet, Inc. II Jan-14-2018
-
-