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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
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 241 241
2022 261 261

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 287 287
Break 143 143
Fracture 108 108
Insufficient Information 104 104
Appropriate Term/Code Not Available 80 80
Loosening of Implant Not Related to Bone-Ingrowth 71 71
Loose or Intermittent Connection 30 30
Crack 27 27
Unstable 24 24
Migration 24 24
Difficult to Insert 19 19
Malposition of Device 18 18
Mechanical Jam 17 17
Connection Problem 16 16
Device Dislodged or Dislocated 16 16
Naturally Worn 15 15
Flaked 15 15
Migration or Expulsion of Device 14 14
Loss of Osseointegration 12 12
Material Fragmentation 11 11
Loss of or Failure to Bond 10 10
Noise, Audible 10 10
Material Deformation 7 7
Corroded 7 7
Fitting Problem 7 7
Material Protrusion/Extrusion 6 6
Material Twisted/Bent 6 6
Defective Device 5 5
Device Appears to Trigger Rejection 5 5
Inadequacy of Device Shape and/or Size 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
Positioning Failure 4 4
Failure to Osseointegrate 4 4
Patient Device Interaction Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Detachment of Device or Device Component 3 3
Device Damaged by Another Device 3 3
Peeled/Delaminated 3 3
Difficult To Position 3 3
Material Erosion 3 3
Off-Label Use 2 2
Overheating of Device 2 2
Material Separation 2 2
Unexpected Therapeutic Results 2 2
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Expiration Date Error 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Material Split, Cut or Torn 2 2
Unintended Application Program Shut Down 1 1
Scratched Material 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Cut In Material 1 1
Dent in Material 1 1
Activation, Positioning or Separation Problem 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Packaging Compromised 1 1
Device Operational Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged Prior to Use 1 1
Unsealed Device Packaging 1 1
Device Slipped 1 1
Smoking 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Incorrect Measurement 1 1
Material Discolored 1 1
Difficult or Delayed Positioning 1 1
Device Reprocessing Problem 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 278 278
No Clinical Signs, Symptoms or Conditions 195 195
Unspecified Infection 106 106
Failure of Implant 85 85
No Known Impact Or Consequence To Patient 85 85
Injury 80 80
Bone Fracture(s) 72 72
No Information 55 55
Insufficient Information 41 41
No Consequences Or Impact To Patient 37 37
Swelling 36 36
Inadequate Osseointegration 33 33
Loss of Range of Motion 31 31
Ambulation Difficulties 23 23
Limited Mobility Of The Implanted Joint 22 22
Swelling/ Edema 21 21
No Code Available 20 20
No Patient Involvement 20 20
Joint Dislocation 18 18
Joint Laxity 17 17
Osteolysis 13 13
Fall 13 13
Arthritis 12 12
Foreign Body In Patient 12 12
Device Embedded In Tissue or Plaque 12 12
Inflammation 11 11
Arthralgia 11 11
Implant Pain 9 9
Numbness 8 8
Synovitis 8 8
Joint Disorder 7 7
Discomfort 7 7
Osteopenia/ Osteoporosis 7 7
Metal Related Pathology 6 6
Unspecified Tissue Injury 5 5
Patient Problem/Medical Problem 5 5
Reaction 5 5
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Subluxation 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, LP II Nov-20-2020
2 Smith & Nephew, Inc. II May-27-2020
3 Zimmer Biomet, Inc. II Mar-28-2018
4 Zimmer Biomet, Inc. II Mar-14-2018
5 Zimmer Biomet, Inc. II Jan-14-2018
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