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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
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
AESCULAP IMPLANT SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSOURCE INC
  SUBSTANTIALLY EQUIVALENT 1
PIPELINE BIOMEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PIPELINE ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
STELKAST COMPANY
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 31 31
2015 52 52
2016 45 45
2017 27 27
2018 39 39
2019 104 104
2020 178 178
2021 88 88
2022 32 32
2023 18 18
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 137 137
Adverse Event Without Identified Device or Use Problem 99 99
Device Dislodged or Dislocated 80 80
Insufficient Information 74 74
Device Contaminated During Manufacture or Shipping 69 69
Break 26 26
Unstable 23 23
Fracture 18 18
Material Integrity Problem 17 17
Packaging Problem 14 14
Difficult to Insert 14 14
Patient Device Interaction Problem 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Unintended Movement 8 8
Loose or Intermittent Connection 8 8
Mechanical Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Material Deformation 7 7
Device Operates Differently Than Expected 7 7
Naturally Worn 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Positioning Problem 5 5
Detachment of Device or Device Component 5 5
Device Slipped 5 5
Microbial Contamination of Device 5 5
Malposition of Device 5 5
Difficult or Delayed Positioning 5 5
Positioning Failure 5 5
Degraded 4 4
Difficult To Position 3 3
Product Quality Problem 3 3
Detachment Of Device Component 3 3
Migration or Expulsion of Device 3 3
Contamination 3 3
Device Markings/Labelling Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Improper or Incorrect Procedure or Method 3 3
Scratched Material 2 2
Noise, Audible 2 2
Migration 2 2
Material Erosion 2 2
Failure To Adhere Or Bond 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 2 2
Use of Device Problem 2 2
Metal Shedding Debris 1 1
Component Missing 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or Separation Problem 1 1
Device Inoperable 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Computer Software Problem 1 1
Disconnection 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Corroded 1 1
Delivered as Unsterile Product 1 1
Unclear Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Physical Resistance 1 1
Device Or Device Fragments Location Unknown 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 154 154
No Known Impact Or Consequence To Patient 82 82
No Patient Involvement 75 75
No Code Available 59 59
Joint Dislocation 59 59
Pain 56 56
No Consequences Or Impact To Patient 38 38
No Clinical Signs, Symptoms or Conditions 26 26
Injury 23 23
Failure of Implant 21 21
Insufficient Information 18 18
No Information 16 16
Loss of Range of Motion 10 10
Fall 10 10
Bone Fracture(s) 9 9
Ambulation Difficulties 9 9
Hip Fracture 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Joint Disorder 6 6
Limited Mobility Of The Implanted Joint 5 5
Joint Laxity 5 5
Metal Related Pathology 5 5
Discomfort 5 5
Synovitis 4 4
Inflammation 4 4
Scar Tissue 3 3
Bacterial Infection 3 3
Swelling 3 3
Post Operative Wound Infection 3 3
Osteolysis 3 3
Implant Pain 3 3
Fluid Discharge 3 3
Foreign Body In Patient 3 3
Patient Problem/Medical Problem 2 2
Unequal Limb Length 2 2
Seroma 2 2
Tissue Damage 2 2
Arthralgia 2 2
Ossification 2 2
Necrosis 1 1
Scarring 1 1
Staphylococcus Aureus 1 1
Cellulitis 1 1
Wound Dehiscence 1 1
Host-Tissue Reaction 1 1
Hematoma 1 1
Fatigue 1 1
Tingling 1 1
Impaired Healing 1 1
Numbness 1 1
Sleep Dysfunction 1 1
Blood Loss 1 1
Skin Infection 1 1
Swelling/ Edema 1 1
Muscle/Tendon Damage 1 1
Inadequate Osseointegration 1 1
Osteopenia/ Osteoporosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Conformis, Inc. II Aug-16-2023
2 Stelkast Co II Apr-07-2013
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