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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 584
Device Dislodged or Dislocated 148
Adverse Event Without Identified Device or Use Problem 82
Break 76
Fracture 73
Corroded 46
Degraded 46
Material Integrity Problem 44
Loss of Osseointegration 42
Mechanical Problem 39
Malposition of device 31
Material Deformation 31
Naturally Worn 31
Migration or Expulsion of Device 29
Loose or Intermittent Connection 25
Appropriate Term/Code Not Available 25
Positioning Problem 18
Osseointegration Problem 16
Metal Shedding Debris 16
Unstable 12
Noise, Audible 12
Device Slipped 10
Material Erosion 10
Device-Device Incompatibility 9
Inadequacy of Device Shape and/or Size 8
Detachment Of Device Component 8
Unintended Movement 8
Packaging Problem 6
No Apparent Adverse Event 6
Migration 6
Difficult to Remove 6
Manufacturing, Packaging or Shipping Problem 5
Device Operates Differently Than Expected 5
Device Contaminated during manufacture or shipping 4
Scratched Material 4
Tip 3
Loosening of Implant Not Related to Bone-Ingrowth 3
Device Contamination with Chemical or Other Material 3
Device Packaging Compromised 3
Detachment of Device or device Component 3
Use of Device Problem 3
Fitting Problem 3
Disassembly 3
Material Discolored 3
Sticking 3
Loss of Power 2
Material Fragmentation 2
Component Falling 2
Adapter (Adaptor) 2
Screw 2
Defective Device 2
Device Markings / Labelling Problem 2
Device Damaged by Another Device 2
Calibration Problem 2
Tear, Rip or Hole in Device Packaging 2
Compatibility Problem 2
Material Protrusion / Extrusion 2
Mechanical Jam 2
Handpiece 1
Trocar 1
Patient Device Interaction Problem 1
Inaccurate Information 1
Contamination / decontamination Problem 1
Connection Problem 1
Contamination of Device Ingredient or Reagent 1
Delamination 1
Device Displays Incorrect Message 1
Failure to Disconnect 1
Separation Failure 1
Patient-Device Incompatibility 1
Biological Environmental Factor 1
Deformation Due to Compressive Stress 1
Device Damaged Prior to Use 1
Defective Component 1
Implant, removal of 1
Device Issue 1
Cups 1
Extractor 1
Heads 1
Plate 1
Ring 1
Accessory Incompatible 1
Failure To Adhere Or Bond 1
Contamination During Use 1
Crack 1
Difficult to Insert 1
Cable 1
Nonstandard device 1
Delivered as Unsterile Product 1
Unsealed Device Packaging 1
Difficult To Position 1
Off-Label Use 1
Incorrect Measurement 1
Unexpected Therapeutic Results 1
Device Inoperable 1
Total Device Problems 1614

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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