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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 6
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
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 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
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
2017 113 113
2018 159 159
2019 177 177
2020 273 273
2021 241 241
2022 140 140

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 262 262
Insufficient Information 144 144
Break 144 144
Fracture 108 108
Appropriate Term/Code Not Available 84 84
Loosening of Implant Not Related to Bone-Ingrowth 63 63
Loose or Intermittent Connection 31 31
Crack 28 28
Unstable 27 27
Migration or Expulsion of Device 22 22
Migration 19 19
Naturally Worn 17 17
Mechanical Jam 16 16
Connection Problem 16 16
Difficult to Insert 15 15
Flaked 15 15
Loss of or Failure to Bond 11 11
Malposition of Device 10 10
Device Dislodged or Dislocated 9 9
Material Fragmentation 9 9
Fitting Problem 8 8
Material Deformation 7 7
Corroded 7 7
Noise, Audible 7 7
Material Protrusion/Extrusion 6 6
Material Twisted/Bent 6 6
Packaging Problem 5 5
Defective Device 5 5
Mechanical Problem 5 5
Device Slipped 5 5
Physical Resistance/Sticking 5 5
No Apparent Adverse Event 4 4
Incomplete or Inadequate Connection 4 4
Patient Device Interaction Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Positioning Failure 4 4
Failure To Adhere Or Bond 4 4
Degraded 4 4
Peeled/Delaminated 3 3
Difficult To Position 3 3
Detachment of Device or Device Component 3 3
Device Operates Differently Than Expected 3 3
Component Missing 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Damaged by Another Device 3 3
Device Packaging Compromised 2 2
Device-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Positioning Problem 2 2
Loss of Osseointegration 2 2
Unexpected Therapeutic Results 2 2
Microbial Contamination of Device 2 2
Activation, Positioning or SeparationProblem 2 2
Expiration Date Error 2 2
Material Separation 2 2
Overheating of Device 2 2
Detachment Of Device Component 2 2
Contamination 1 1
Difficult or Delayed Positioning 1 1
Device Reprocessing Problem 1 1
Material Discolored 1 1
Incorrect Measurement 1 1
Unsealed Device Packaging 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Misconnection 1 1
Patient-Device Incompatibility 1 1
Device Operational Issue 1 1
Device Damaged Prior to Use 1 1
Cut In Material 1 1
Dent in Material 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Scratched Material 1 1
Unintended Movement 1 1
Material Integrity Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Unintended Application Program Shut Down 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 294 294
No Clinical Signs, Symptoms or Conditions 177 177
Unspecified Infection 103 103
No Known Impact Or Consequence To Patient 97 97
Injury 96 96
Failure of Implant 79 79
No Information 75 75
Bone Fracture(s) 74 74
Swelling 50 50
No Consequences Or Impact To Patient 40 40
No Code Available 38 38
Limited Mobility Of The Implanted Joint 26 26
Loss of Range of Motion 23 23
Ambulation Difficulties 21 21
No Patient Involvement 21 21
Insufficient Information 18 18
Swelling/ Edema 16 16
Inadequate Osseointegration 13 13
Foreign Body In Patient 13 13
Device Embedded In Tissue or Plaque 12 12
Fall 12 12
Inflammation 11 11
Joint Dislocation 11 11
Osteolysis 10 10
Discomfort 10 10
Joint Laxity 8 8
Joint Disorder 8 8
Synovitis 8 8
Arthralgia 8 8
Cyst(s) 7 7
Implant Pain 7 7
Osteopenia/ Osteoporosis 7 7
Patient Problem/Medical Problem 6 6
Arthritis 6 6
Reaction 5 5
Numbness 5 5
Metal Related Pathology 5 5
Joint Swelling 4 4
Damage to Ligament(s) 4 4
Necrosis 4 4
Wound Dehiscence 3 3
Abscess 3 3
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Embolism/Embolus 3 3
Toxicity 2 2
Laceration(s) 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Erosion 2 2
Deformity/ Disfigurement 2 2
Tissue Damage 1 1
Weakness 1 1
Nerve Damage 1 1
Muscular Rigidity 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Cellulitis 1 1
Debris, Bone Shedding 1 1
Edema 1 1
Ossification 1 1
Bacterial Infection 1 1
Fatigue 1 1
Inadequate Pain Relief 1 1
Subluxation 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Nov-16-2017
2 Encore Medical, LP II Nov-20-2020
3 Smith & Nephew, Inc. II May-27-2020
4 Zimmer Biomet, Inc. II Mar-28-2018
5 Zimmer Biomet, Inc. II Mar-14-2018
6 Zimmer Biomet, Inc. II Jan-14-2018
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