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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 0

Device Problems
Insufficient Information 333
Appropriate Term/Code Not Available 310
Adverse Event Without Identified Device or Use Problem 230
Patient Device Interaction Problem 152
Metal Shedding Debris 28
Device Operates Differently Than Expected 15
Unintended Movement 15
Device Dislodged or Dislocated 9
Material Integrity Problem 9
Noise, Audible 9
Fracture 8
Mechanical Problem 8
Break 6
Loose or Intermittent Connection 6
Degraded 5
Patient-Device Incompatibility 5
Unstable 4
Naturally Worn 4
Malposition of device 4
Improper or Incorrect Procedure or Method 3
Detachment of Device or device Component 3
Migration or Expulsion of Device 3
Loss of Osseointegration 3
Use of Device Problem 2
Device Slipped 2
Connection Problem 2
No Apparent Adverse Event 1
Premature system activation 1
Insufficient Flow or Under Infusion 1
Difficult to Remove 1
Contamination of Device Ingredient or Reagent 1
Premature explantation 1
Off-Label Use 1
Collapse 1
Cannula 1
No Fail-Safe Mechanism 1
Difficult or Delayed Positioning 1
Failure to Align 1
Osseointegration Problem 1
Bent 1
Pitted 1
High Test Results 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Material Erosion 1
Inadequacy of Device Shape and/or Size 1
Screw 1
Cups 1
Fitting Problem 1
Crack 1
Failure to Cut 1
Sticking 1
Positioning Problem 1
Total Device Problems 1204

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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