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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/metal, resurfacing
Definition Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
Product CodeNXT
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
2 3 1 2 0 1

Device Problems
Adverse Event Without Identified Device or Use Problem 473
Insufficient Information 399
Patient Device Interaction Problem 332
Appropriate Term/Code Not Available 306
Compatibility Problem 34
Metal Shedding Debris 28
Device Operates Differently Than Expected 15
Unintended Movement 15
Loose or Intermittent Connection 15
Break 14
Fracture 12
Noise, Audible 9
Device Dislodged or Dislocated 8
Material Integrity Problem 8
Mechanical Problem 8
Pitted 6
Patient-Device Incompatibility 6
Unstable 5
Degraded 5
Loss of Osseointegration 5
Migration or Expulsion of Device 4
Loosening of Implant Not Related to Bone-Ingrowth 4
Malposition of Device 4
Naturally Worn 4
Detachment of Device or Device Component 3
Improper or Incorrect Procedure or Method 3
Device Slipped 2
Connection Problem 2
Use of Device Problem 2
Dull, Blunt 2
Inadequacy of Device Shape and/or Size 1
Loss of or Failure to Bond 1
Screw 1
Cup 1
Fitting Problem 1
Crack 1
Failure to Cut 1
Sticking 1
Positioning Problem 1
Bent 1
Device Appears to Trigger Rejection 1
Material Erosion 1
High Test Results 1
No Apparent Adverse Event 1
Premature system activation 1
Insufficient Flow or Under Infusion 1
Migration 1
Contamination of Device Ingredient or Reagent 1
Difficult to Remove 1
Inaccurate Delivery 1
Difficult or Delayed Positioning 1
Failure to Align 1
Contamination 1
Cannula 1
No Fail-Safe Mechanism 1
Premature explantation 1
Off-Label Use 1
Collapse 1
Total Device Problems 1761

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II May-21-2018
2 Smith & Nephew, Inc. II Sep-10-2015

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