• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 7
BIOMET MANUFACTUTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICONACY
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
NOVOSOURCE INC
  SUBSTANTIALLY EQUIVALENT 1
OMNI
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 4
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Insufficient Information 6704
Device Dislodged or Dislocated 3453
Appropriate Term/Code Not Available 2247
Adverse Event Without Identified Device or Use Problem 2162
Loss of Osseointegration 1728
Corroded 962
Fracture 915
Naturally Worn 828
Malposition of device 715
Disassembly 672
Migration or Expulsion of Device 527
Break 489
Noise, Audible 424
Metal Shedding Debris 418
Loose or Intermittent Connection 345
Biocompatibility 334
Osseointegration Problem 333
Material Deformation 313
Material Integrity Problem 287
Material Erosion 276
Mechanical Problem 235
Unstable 222
Degraded 187
Difficult to Insert 175
Positioning Problem 149
Packaging Problem 141
Material Disintegration 132
Device Operates Differently Than Expected 108
Loss of or Failure to Bond 97
Fitting Problem 91
Migration 90
Failure To Adhere Or Bond 84
Difficult to Remove 84
Detachment of Device or device Component 74
Manufacturing, Packaging or Shipping Problem 67
Inadequacy of Device Shape and/or Size 67
Material Separation 64
Detachment Of Device Component 58
Failure to Osseointegrate 57
Tear, Rip or Hole in Device Packaging 52
Device Packaging Compromised 51
Device Slipped 50
Use of Device Problem 48
No Apparent Adverse Event 48
Scratched Material 47
Separation Failure 46
Device Contamination with Chemical or Other Material 44
Separation Problem 44
Material Discolored 43
Compatibility Problem 41
Unintended Movement 40
Difficult To Position 36
Device-Device Incompatibility 34
Loosening of Implant Not Related to Bone-Ingrowth 33
Crack 30
Device Contaminated during manufacture or shipping 29
Mechanical Jam 25
Material Distortion 24
Bent 23
Sticking 20
Connection Problem 17
Component Missing 16
Material Twisted / Bent 16
Screw 15
Component or Accessory Incompatibility 15
Device Markings / Labelling Problem 15
Dull, Blunt 14
Delamination 14
Patient-Device Incompatibility 13
Device Damaged by Another Device 13
Physical Resistance / Sticking 13
Tip 12
Contamination / decontamination Problem 12
Cups 11
Product Quality Problem 11
Material Fragmentation 11
Out-Of-Box Failure 10
Disconnection 10
Device Damaged Prior to Use 10
Delivered as Unsterile Product 10
Shipping Damage or Problem 10
Defective Device 9
Component Incompatible 8
Misassembly by Users 7
Difficult to Open or Remove Packaging Material 7
Mechanics Altered 7
Shaft 7
Difficult or Delayed Positioning 7
Improper or Incorrect Procedure or Method 6
Misconnection 6
Positioning Failure 6
Off-Label Use 6
Unsealed Device Packaging 5
Material Protrusion / Extrusion 5
Device Issue 5
Entrapment of Device 5
Device Expiration Issue 5
Nonstandard device 5
Misassembled 5
Device Difficult to Setup or Prepare 4
Total Device Problems 27505

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-29-2015
2 Biomet, Inc. III Jun-11-2015
3 Biomet, Inc. II Feb-17-2015
4 CORENTEC CO., LTD II Mar-13-2017
5 Conformis, Inc. II Jun-13-2019
6 Conformis, Inc. II Jan-12-2019
7 Djo Surgical II Mar-04-2014
8 Encore Medical, Lp II Jul-19-2016
9 Exactech, Inc. II Jan-17-2017
10 Exactech, Inc. II Feb-03-2014
11 Howmedica Osteonics Corp. II Mar-09-2018
12 OMNIlife science Inc. II Jul-25-2018
13 Omnilife Science Inc. II Aug-21-2015
14 Signal Medical Corporation II Oct-22-2014
15 Smith & Nephew, Inc. II Mar-20-2019
16 Stryker Howmedica Osteonics Corp. II Jul-25-2016
17 Stryker Howmedica Osteonics Corp. II Nov-10-2015
18 Stryker Howmedica Osteonics Corp. II Sep-23-2015
19 Stryker Howmedica Osteonics Corp. II May-19-2015
20 Zimmer Biomet, Inc. II Jul-05-2018
21 Zimmer Biomet, Inc. II Apr-27-2018
22 Zimmer Biomet, Inc. II Mar-14-2018
23 Zimmer Biomet, Inc. II Mar-14-2018
24 Zimmer Biomet, Inc. II Mar-09-2018
25 Zimmer Biomet, Inc. II Feb-26-2018
26 Zimmer Biomet, Inc. II Jan-04-2018
27 Zimmer Biomet, Inc. II Mar-20-2017
28 Zimmer Biomet, Inc. II Jan-13-2017
29 Zimmer Biomet, Inc. II Mar-04-2016
30 Zimmer Biomet, Inc. II Feb-22-2016
31 Zimmer Gmbh II Feb-20-2015
32 Zimmer Inc. II Jun-26-2015
33 Zimmer Manufacturing B.V. II May-16-2016
34 Zimmer Manufacturing B.V. II Mar-12-2016
35 Zimmer Manufacturing B.V. II Dec-24-2014
36 Zimmer Manufacturing B.V. II Dec-17-2014
37 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
38 Zimmer, Inc. II Jul-10-2014
39 Zimmer, Inc. II Jun-20-2014
40 Zimmer, Inc. II Apr-24-2014
41 Zimmer, Inc. II Feb-20-2014

-
-