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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220930  Restoris Multi-Compartmental Knee System
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
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
2019 177 177
2020 273 273
2021 240 240
2022 259 259
2023 231 231
2024 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 358 358
Fracture 168 168
Break 145 145
Loosening of Implant Not Related to Bone-Ingrowth 99 99
Appropriate Term/Code Not Available 73 73
Insufficient Information 54 54
Migration 34 34
Crack 27 27
Unstable 26 26
Device Dislodged or Dislocated 23 23
Loose or Intermittent Connection 22 22
Mechanical Jam 21 21
Naturally Worn 20 20
Difficult to Insert 19 19
Flaked 16 16
Connection Problem 16 16
Malposition of Device 14 14
Device Appears to Trigger Rejection 14 14
Loss of Osseointegration 14 14
Material Fragmentation 13 13
Fitting Problem 12 12
Loss of or Failure to Bond 10 10
Positioning Failure 9 9
Material Deformation 9 9
Material Twisted/Bent 9 9
Noise, Audible 9 9
Failure to Osseointegrate 8 8
Corroded 7 7
Degraded 6 6
Material Protrusion/Extrusion 6 6
Migration or Expulsion of Device 5 5
Material Erosion 4 4
Device Damaged by Another Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Defective Device 4 4
Patient Device Interaction Problem 4 4
Incomplete or Inadequate Connection 4 4
Packaging Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Separation 2 2
Peeled/Delaminated 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 2 2
Microbial Contamination of Device 2 2
Overheating of Device 2 2
Mechanical Problem 2 2
Osseointegration Problem 2 2
Physical Resistance/Sticking 2 2
Detachment of Device or Device Component 2 2
Expiration Date Error 2 2
Separation Failure 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1
Unintended Application Program Shut Down 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1
Mechanics Altered 1 1
Unsealed Device Packaging 1 1
Material Discolored 1 1
Device Reprocessing Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dent in Material 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 307 307
No Clinical Signs, Symptoms or Conditions 266 266
Failure of Implant 117 117
Unspecified Infection 115 115
Insufficient Information 73 73
No Known Impact Or Consequence To Patient 72 72
Bone Fracture(s) 67 67
Injury 52 52
Inadequate Osseointegration 45 45
No Information 35 35
No Consequences Or Impact To Patient 30 30
Swelling 29 29
Joint Laxity 29 29
Loss of Range of Motion 27 27
Swelling/ Edema 26 26
Ambulation Difficulties 25 25
Joint Dislocation 25 25
Foreign Body In Patient 22 22
Device Embedded In Tissue or Plaque 21 21
Fall 19 19
No Patient Involvement 18 18
Arthralgia 16 16
Osteolysis 15 15
Limited Mobility Of The Implanted Joint 15 15
Implant Pain 15 15
Inflammation 12 12
No Code Available 11 11
Metal Related Pathology 10 10
Arthritis 10 10
Synovitis 9 9
Discomfort 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Numbness 8 8
Osteopenia/ Osteoporosis 7 7
Joint Disorder 5 5
Reaction 5 5
Damage to Ligament(s) 5 5
Necrosis 5 5
Cyst(s) 4 4
Wound Dehiscence 4 4
Unspecified Tissue Injury 4 4
Embolism/Embolus 3 3
Joint Swelling 3 3
Deformity/ Disfigurement 3 3
Patient Problem/Medical Problem 3 3
Abscess 3 3
Scar Tissue 3 3
Muscular Rigidity 2 2
Adhesion(s) 2 2
Laceration(s) 2 2
Erosion 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Infiltration into Tissue 1 1
Ossification 1 1
Debris, Bone Shedding 1 1
Bacterial Infection 1 1
Nerve Damage 1 1
Sepsis 1 1
Toxicity 1 1
Rupture 1 1
Weakness 1 1
Burning Sensation 1 1
Thromboembolism 1 1
Post Operative Wound Infection 1 1
Muscle/Tendon Damage 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
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