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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, non-porous, calcium phosphate
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 556
Device Dislodged or Dislocated 137
Adverse Event Without Identified Device or Use Problem 77
Fracture 71
Break 63
Corroded 44
Material Integrity Problem 43
Degraded 42
Loss of Osseointegration 41
Mechanical Problem 38
Material Deformation 31
Naturally Worn 29
Malposition of device 29
Migration or Expulsion of Device 29
Appropriate Term/Code Not Available 25
Loose or Intermittent Connection 24
Positioning Problem 18
Metal Shedding Debris 16
Osseointegration Problem 15
Unstable 11
Noise, Audible 11
Device Slipped 10
Material Erosion 9
Device-Device Incompatibility 9
Detachment Of Device Component 8
Inadequacy of Device Shape and/or Size 8
Unintended Movement 8
Packaging Problem 6
Migration 6
Difficult to Remove 6
No Apparent Adverse Event 6
Device Operates Differently Than Expected 5
Manufacturing, Packaging or Shipping Problem 5
Scratched Material 4
Detachment of Device or device Component 3
Sticking 3
Fitting Problem 3
Device Contamination with Chemical or Other Material 3
Device Contaminated during manufacture or shipping 3
Device Packaging Compromised 3
Loosening of Implant Not Related to Bone-Ingrowth 3
Material Discolored 3
Use of Device Problem 3
Tip 3
Disassembly 3
Screw 2
Compatibility Problem 2
Device Damaged by Another Device 2
Material Protrusion / Extrusion 2
Material Fragmentation 2
Loss of Power 2
Adapter (Adaptor) 2
Defective Device 2
Calibration Problem 2
Component Falling 2
Device Markings / Labelling Problem 2
Difficult to Insert 1
Device Damaged Prior to Use 1
Failure to Disconnect 1
Implant, removal of 1
Nonstandard device 1
Difficult To Position 1
Off-Label Use 1
Device Issue 1
Separation Failure 1
Unsealed Device Packaging 1
Extractor 1
Plate 1
Ring 1
Mechanical Jam 1
Patient Device Interaction Problem 1
Inaccurate Information 1
Biological Environmental Factor 1
Contamination of Device Ingredient or Reagent 1
Trocar 1
Accessory Incompatible 1
Handpiece 1
Unexpected Therapeutic Results 1
Device Inoperable 1
Defective Component 1
Tear, Rip or Hole in Device Packaging 1
Failure To Adhere Or Bond 1
Contamination During Use 1
Cable 1
Cups 1
Patient-Device Incompatibility 1
Heads 1
Incorrect Measurement 1
Deformation Due to Compressive Stress 1
Delamination 1
Delivered as Unsterile Product 1
Device Displays Incorrect Message 1
Contamination / decontamination Problem 1
Connection Problem 1
Total Device Problems 1533

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Orthopaedics Inc. II Nov-21-2016
2 Exactech, Inc. II Jan-18-2018
3 Exactech, Inc. II Nov-02-2015
4 Signature Orthopedics Pty Limited II Mar-06-2018
5 Smith & Nephew, Inc. II Jan-04-2017
6 Smith & Nephew, Inc. II Jul-28-2016
7 Stryker Howmedica Osteonics Corp. II Feb-03-2015
8 Stryker Howmedica Osteonics Corp. II Apr-02-2014
9 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
10 Zimmer Gmbh II Feb-20-2015

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