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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 14 14

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 104 104
Device Dislodged or Dislocated 83 83
Insufficient Information 74 74
Device Contaminated During Manufacture or Shipping 69 69
Unstable 26 26
Break 26 26
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
Inadequacy of Device Shape and/or Size 7 7
Material Deformation 7 7
Device Operates Differently Than Expected 7 7
Mechanical Problem 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Naturally Worn 6 6
Detachment of Device or Device Component 5 5
Difficult or Delayed Positioning 5 5
Positioning Failure 5 5
Microbial Contamination of Device 5 5
Positioning Problem 5 5
Malposition of Device 5 5
Device Slipped 5 5
Degraded 4 4
Contamination 3 3
Improper or Incorrect Procedure or Method 3 3
Device Markings/Labelling Problem 3 3
Migration or Expulsion of Device 3 3
Detachment Of Device Component 3 3
Difficult To Position 3 3
Product Quality Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Scratched Material 2 2
Failure To Adhere Or Bond 2 2
Device Difficult to Setup or Prepare 2 2
Use of Device Problem 2 2
Material Erosion 2 2
Material Separation 2 2
Migration 2 2
Noise, Audible 2 2
Device Inoperable 1 1
Corroded 1 1
Device Or Device Fragments Location Unknown 1 1
Device Appears to Trigger Rejection 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 156 156
No Known Impact Or Consequence To Patient 82 82
No Patient Involvement 75 75
Joint Dislocation 63 63
No Code Available 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 22 22
Insufficient Information 19 19
No Information 16 16
Fall 10 10
Loss of Range of Motion 10 10
Ambulation Difficulties 9 9
Bone Fracture(s) 9 9
Joint Laxity 8 8
Joint Disorder 6 6
Hip Fracture 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Limited Mobility Of The Implanted Joint 5 5
Metal Related Pathology 5 5
Discomfort 5 5
Inflammation 4 4
Synovitis 4 4
Bacterial Infection 3 3
Implant Pain 3 3
Fluid Discharge 3 3
Post Operative Wound Infection 3 3
Foreign Body In Patient 3 3
Scar Tissue 3 3
Swelling 3 3
Osteolysis 3 3
Tissue Damage 2 2
Ossification 2 2
Arthralgia 2 2
Seroma 2 2
Patient Problem/Medical Problem 2 2
Unequal Limb Length 2 2
Impaired Healing 1 1
Sleep Dysfunction 1 1
Swelling/ Edema 1 1
Host-Tissue Reaction 1 1
Muscle/Tendon Damage 1 1
Skin Infection 1 1
Wound Dehiscence 1 1
Numbness 1 1
Tingling 1 1
Staphylococcus Aureus 1 1
Cellulitis 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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