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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, 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 5
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 2
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICONACY
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 3
OMNI
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Insufficient Information 7291
Adverse Event Without Identified Device or Use Problem 5061
Device Dislodged or Dislocated 4237
Appropriate Term/Code Not Available 2119
Loss of Osseointegration 2110
Corroded 1239
Fracture 1098
Naturally Worn 1047
Malposition of device 813
Osseointegration Problem 799
Disassembly 654
Material Erosion 535
Migration or Expulsion of Device 525
Break 492
Degraded 453
Noise, Audible 448
Metal Shedding Debris 347
Biocompatibility 337
Loose or Intermittent Connection 335
Material Deformation 320
Material Integrity Problem 287
Unstable 287
Mechanical Problem 249
Difficult to Insert 231
Migration 219
Use of Device Problem 216
Packaging Problem 201
Positioning Problem 160
Device Contaminated during manufacture or shipping 157
Loss of or Failure to Bond 136
Difficult to Remove 136
Detachment of Device or device Component 117
Device Operates Differently Than Expected 102
Material Disintegration 93
Fitting Problem 81
Tear, Rip or Hole in Device Packaging 77
Inadequacy of Device Shape and/or Size 75
Failure To Adhere Or Bond 72
Material Separation 70
Failure to Osseointegrate 69
Manufacturing, Packaging or Shipping Problem 69
Unintended Movement 68
Loosening of Implant Not Related to Bone-Ingrowth 60
Device-Device Incompatibility 59
Separation Failure 59
Detachment Of Device Component 56
No Apparent Adverse Event 53
Device Packaging Compromised 49
Scratched Material 48
Separation Problem 47
Device Contamination with Chemical or Other Material 46
Device Slipped 43
Compatibility Problem 40
Material Discolored 38
Difficult To Position 35
Mechanical Jam 33
Crack 30
Positioning Failure 30
Material Distortion 23
Component Misassembled 23
Bent 23
Material Twisted / Bent 22
Sticking 19
Connection Problem 19
Device Markings / Labelling Problem 19
Patient-Device Incompatibility 19
Contamination / decontamination Problem 18
Material Fragmentation 17
Component Missing 15
Device Damaged by Another Device 15
Component or Accessory Incompatibility 15
Screw 14
Dull, Blunt 14
Difficult or Delayed Separation 14
Device Difficult to Setup or Prepare 14
Delamination 14
Physical Resistance / Sticking 14
Product Quality Problem 13
Defective Device 12
Delivered as Unsterile Product 12
Disconnection 12
Device Damaged Prior to Use 11
Tip 11
Out-Of-Box Failure 10
Cups 10
Difficult or Delayed Positioning 10
Shipping Damage or Problem 10
Off-Label Use 9
Patient Device Interaction Problem 9
Component Incompatible 8
Difficult to Open or Remove Packaging Material 8
Improper or Incorrect Procedure or Method 7
Mechanics Altered 7
Shaft 7
Misconnection 7
Unsealed Device Packaging 6
Misassembly by Users 6
Labelling, Instructions for Use or Training Problem 6
Nonstandard device 5
Entrapment of Device 5
Total Device Problems 34690

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 Oct-08-2019
6 Conformis, Inc. II Jun-13-2019
7 Conformis, Inc. II Jan-12-2019
8 Encore Medical, LP II May-08-2020
9 Encore Medical, LP II Apr-10-2020
10 Encore Medical, Lp II Jul-19-2016
11 Exactech, Inc. II Jan-17-2017
12 Howmedica Osteonics Corp. II May-07-2020
13 Howmedica Osteonics Corp. II Nov-22-2019
14 Howmedica Osteonics Corp. II Mar-09-2018
15 OMNIlife science Inc. II Oct-21-2019
16 OMNIlife science Inc. II Sep-05-2019
17 OMNIlife science Inc. II Jul-25-2018
18 Omnilife Science Inc. II Aug-21-2015
19 Smith & Nephew, Inc. II Mar-20-2019
20 Stryker Howmedica Osteonics Corp. II Jul-25-2016
21 Stryker Howmedica Osteonics Corp. II Nov-10-2015
22 Stryker Howmedica Osteonics Corp. II Sep-23-2015
23 Stryker Howmedica Osteonics Corp. II May-19-2015
24 Zimmer Biomet, Inc. II Nov-22-2019
25 Zimmer Biomet, Inc. II Nov-07-2019
26 Zimmer Biomet, Inc. II Jul-05-2018
27 Zimmer Biomet, Inc. II Apr-27-2018
28 Zimmer Biomet, Inc. II Mar-14-2018
29 Zimmer Biomet, Inc. II Mar-14-2018
30 Zimmer Biomet, Inc. II Mar-09-2018
31 Zimmer Biomet, Inc. II Feb-26-2018
32 Zimmer Biomet, Inc. II Jan-04-2018
33 Zimmer Biomet, Inc. II Mar-20-2017
34 Zimmer Biomet, Inc. II Jan-13-2017
35 Zimmer Biomet, Inc. II Mar-04-2016
36 Zimmer Biomet, Inc. II Feb-22-2016
37 Zimmer Gmbh II Feb-20-2015
38 Zimmer Inc. II Jun-26-2015
39 Zimmer Manufacturing B.V. II May-16-2016
40 Zimmer Manufacturing B.V. II Mar-12-2016
41 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016

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