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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Definition 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Product CodeOQG
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 88 88
2022 32 33
2023 18 19
2024 20 20
2025 16 16
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 62 62
Device Dislodged or Dislocated 21 21
Unstable 10 10
Difficult to Insert 8 8
Patient Device Interaction Problem 7 8
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Unintended Movement 4 4
Fracture 3 3
Detachment of Device or Device Component 3 3
Product Quality Problem 3 3
Positioning Failure 2 2
Patient-Device Incompatibility 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Migration 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Integrity Problem 2 2
Insufficient Device Problem Information 2 2
Material Deformation 2 2
Packaging Problem 2 2
Activation, Positioning or Separation Problem 1 1
Unclear Information 1 1
Migration or Expulsion of Device 1 1
Positioning Problem 1 1
Loss of or Failure to Bond 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Appears to Trigger Rejection 1 1
Mechanical Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1
Naturally Worn 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 38 39
Joint Dislocation 27 27
No Clinical Signs, Symptoms or Conditions 24 24
Joint Laxity 21 21
Insufficient Information 20 21
Pain 18 19
Failure of Implant 14 15
Medical device site infection 7 7
Bone Fracture(s) 5 6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Fall 5 5
Ambulation or Postural Difficulties 4 4
Loss of Range of Motion 3 3
Osteolysis 3 4
Implant Pain 3 3
Metal Related Pathology 3 4
Post Operative Wound Infection 2 2
Bacterial Infection 2 2
Inflammation 2 2
Unequal Limb Length 2 2
Seroma 2 2
No Consequences Or Impact To Patient 1 1
Wound Dehiscence 1 1
Skin Infection 1 1
Hematoma 1 1
Impaired Healing 1 1
Periprosthetic fracture 1 1
Cellulitis 1 1
Swelling/ Edema 1 2
No Known Impact Or Consequence To Patient 1 1
Discomfort 1 1
No Code Available 1 1
Fluid Discharge 1 1
Extraskeletal ossification 1 1
Muscle/Tendon Damage 1 1
Sleep Dysfunction 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Conformis, Inc. II Aug-16-2023
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