Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 70 70
Appropriate Term/Code Not Available 35 36
Device Dislodged or Dislocated 26 26
Unstable 8 8
Difficult to Insert 8 8
Patient Device Interaction Problem 6 7
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Unintended Movement 4 4
Fracture 4 4
Product Quality Problem 3 3
Naturally Worn 3 4
Loose or Intermittent Connection 3 3
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Positioning Failure 2 2
Material Deformation 2 2
Packaging Problem 2 2
Detachment of Device or Device Component 2 2
Migration 2 2
Activation, Positioning or Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Unclear Information 1 1
Microbial Contamination of Device 1 1
Material Separation 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Appears to Trigger Rejection 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 37 38
Joint Dislocation 24 24
No Clinical Signs, Symptoms or Conditions 24 24
Insufficient Information 20 21
Pain 18 19
Joint Laxity 17 17
Failure of Implant 13 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Fall 5 5
Bone Fracture(s) 4 5
Ambulation Difficulties 4 4
Metal Related Pathology 3 4
Implant Pain 3 3
Loss of Range of Motion 3 3
Osteolysis 3 4
Inflammation 2 2
Post Operative Wound Infection 2 2
Seroma 2 2
Unequal Limb Length 2 2
Bacterial Infection 2 2
Skin Infection 1 1
Sleep Dysfunction 1 1
Impaired Healing 1 1
Wound Dehiscence 1 1
Hip Fracture 1 1
No Code Available 1 1
No Known Impact Or Consequence To Patient 1 1
Cellulitis 1 1
Ossification 1 1
Discomfort 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 2
No Consequences Or Impact To Patient 1 1

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