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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, uncemented, metal/polymer, porous
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeMBL
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Insufficient Information 109
Device Dislodged or Dislocated 56
Adverse Event Without Identified Device or Use Problem 37
Loose or Intermittent Connection 16
Unintended Movement 12
Connection Problem 10
Appropriate Term/Code Not Available 7
Fracture 6
Migration or Expulsion of Device 6
Fitting Problem 6
Unstable 5
Break 3
Mechanical Problem 3
Device Slipped 2
Malposition of device 2
Positioning Problem 2
Difficult to Insert 2
High Test Results 2
Misassembled 1
No Apparent Adverse Event 1
Degraded 1
Metal Shedding Debris 1
Osseointegration Problem 1
Failure To Adhere Or Bond 1
Corroded 1
Misconnection 1
Device Operates Differently Than Expected 1
Illegible Information 1
Calibration Problem 1
Detachment of Device or device Component 1
Naturally Worn 1
Loss of Osseointegration 1
Device-Device Incompatibility 1
Physical Resistance / Sticking 1
Cover 1
Detachment Of Device Component 1
Leak / Splash 1
Inadequacy of Device Shape and/or Size 1
Off-Label Use 1
Material Separation 1
Total Device Problems 308

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics, Inc. I Sep-28-2015
2 Smith & Nephew Inc II Feb-21-2014

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