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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Definition Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use.
Product CodeOIY
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPEDICS INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 121 121
2021 382 382
2022 42 42
2023 40 40
2024 35 35
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 374 374
Appropriate Term/Code Not Available 78 78
Unstable 53 53
Loss of or Failure to Bond 31 31
Fracture 30 30
Difficult to Insert 13 13
Naturally Worn 12 12
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Noise, Audible 8 8
Device Contaminated During Manufacture or Shipping 7 7
Loose or Intermittent Connection 7 7
Migration 7 7
Device Dislodged or Dislocated 6 6
Patient Device Interaction Problem 6 6
Insufficient Information 5 5
Off-Label Use 4 4
Break 4 4
Use of Device Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Device Damaged Prior to Use 3 3
Detachment of Device or Device Component 3 3
Inadequacy of Device Shape and/or Size 2 2
Material Erosion 2 2
Difficult to Open or Remove Packaging Material 2 2
Patient-Device Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1
Degraded 1 1
Inaccurate Information 1 1
Mechanical Problem 1 1
Excessive Cooling 1 1
Defective Device 1 1
Material Too Rigid or Stiff 1 1
Therapeutic or Diagnostic Output Failure 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 176 176
Joint Laxity 109 109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 84 84
Unspecified Infection 74 74
Insufficient Information 58 58
Loss of Range of Motion 55 55
Adhesion(s) 45 45
Fall 33 33
Muscular Rigidity 31 31
Failure of Implant 26 26
No Code Available 25 25
No Clinical Signs, Symptoms or Conditions 24 24
Ambulation Difficulties 19 19
Swelling/ Edema 18 18
Synovitis 18 18
No Known Impact Or Consequence To Patient 18 18
Osteolysis 13 13
Limited Mobility Of The Implanted Joint 12 12
Inflammation 11 11
Discomfort 10 10
Swelling 9 9
Scar Tissue 9 9
Implant Pain 6 6
Joint Dislocation 6 6
Bone Fracture(s) 6 6
No Patient Involvement 6 6
No Information 5 5
Wound Dehiscence 5 5
Cyst(s) 4 4
Ossification 4 4
Necrosis 4 4
Metal Related Pathology 4 4
Hypersensitivity/Allergic reaction 4 4
Granuloma 3 3
Edema 3 3
Muscle/Tendon Damage 3 3
Hematoma 3 3
Limb Fracture 2 2
Foreign Body Reaction 2 2
No Consequences Or Impact To Patient 2 2
Reaction 2 2
Fluid Discharge 1 1
Sepsis 1 1
Bacterial Infection 1 1
Syncope 1 1
Thrombosis/Thrombus 1 1
Rupture 1 1
Hemorrhage/Bleeding 1 1
Nerve Damage 1 1
Retinal Tear 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Conformis, Inc. II Feb-13-2023
2 DePuy Orthopaedics, Inc. II Mar-17-2023
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