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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 107
Device Dislodged or Dislocated 55
Adverse Event Without Identified Device or Use Problem 37
Loose or Intermittent Connection 16
Unintended Movement 12
Connection Problem 8
Appropriate Term/Code Not Available 7
Fracture 6
Fitting Problem 6
Migration or Expulsion of Device 5
Unstable 4
Mechanical Problem 3
Device Slipped 2
Break 2
Malposition of device 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
Positioning Problem 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 299

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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