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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 7
BIOMET MANUFACTUTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
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 3
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 8
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 3

Device Problems
Insufficient Information 7094
Device Dislodged or Dislocated 3863
Adverse Event Without Identified Device or Use Problem 2992
Appropriate Term/Code Not Available 2322
Loss of Osseointegration 1953
Corroded 1125
Fracture 999
Naturally Worn 989
Malposition of device 760
Disassembly 675
Migration or Expulsion of Device 539
Break 501
Osseointegration Problem 460
Noise, Audible 453
Metal Shedding Debris 428
Material Erosion 399
Loose or Intermittent Connection 358
Biocompatibility 334
Material Deformation 319
Material Integrity Problem 292
Unstable 248
Mechanical Problem 247
Degraded 223
Difficult to Insert 198
Packaging Problem 164
Positioning Problem 158
Migration 148
Material Disintegration 132
Loss of or Failure to Bond 115
Difficult to Remove 113
Device Operates Differently Than Expected 108
Fitting Problem 94
Failure To Adhere Or Bond 84
Detachment of Device or device Component 80
Use of Device Problem 72
Inadequacy of Device Shape and/or Size 71
Manufacturing, Packaging or Shipping Problem 69
Material Separation 68
Tear, Rip or Hole in Device Packaging 59
Detachment Of Device Component 58
Failure to Osseointegrate 58
Separation Failure 52
Device Packaging Compromised 51
Device Slipped 50
No Apparent Adverse Event 50
Unintended Movement 49
Scratched Material 48
Separation Problem 47
Material Discolored 45
Device Contamination with Chemical or Other Material 45
Device Contaminated during manufacture or shipping 42
Compatibility Problem 42
Device-Device Incompatibility 42
Loosening of Implant Not Related to Bone-Ingrowth 39
Difficult To Position 36
Crack 30
Mechanical Jam 29
Material Distortion 24
Bent 23
Sticking 20
Material Twisted / Bent 19
Connection Problem 18
Component Missing 16
Device Markings / Labelling Problem 15
Component or Accessory Incompatibility 15
Screw 15
Dull, Blunt 14
Patient-Device Incompatibility 14
Delamination 14
Contamination / decontamination Problem 14
Material Fragmentation 13
Physical Resistance / Sticking 13
Device Damaged by Another Device 13
Tip 12
Product Quality Problem 11
Cups 11
Delivered as Unsterile Product 11
Positioning Failure 11
Shipping Damage or Problem 10
Disconnection 10
Device Damaged Prior to Use 10
Out-Of-Box Failure 10
Defective Device 10
Component Incompatible 8
Difficult or Delayed Positioning 8
Misassembly by Users 7
Difficult to Open or Remove Packaging Material 7
Mechanics Altered 7
Patient Device Interaction Problem 7
Shaft 7
Misconnection 6
Improper or Incorrect Procedure or Method 6
Off-Label Use 6
Device Difficult to Setup or Prepare 5
Nonstandard device 5
Unsealed Device Packaging 5
Entrapment of Device 5
Material Protrusion / Extrusion 5
Difficult or Delayed Separation 5
Device Expiration Issue 5
Total Device Problems 30589

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 Djo Surgical II Mar-04-2014
9 Encore Medical, Lp II Jul-19-2016
10 Exactech, Inc. II Jan-17-2017
11 Exactech, Inc. II Feb-03-2014
12 Howmedica Osteonics Corp. II Mar-09-2018
13 OMNIlife science Inc. II Oct-21-2019
14 OMNIlife science Inc. II Sep-05-2019
15 OMNIlife science Inc. II Jul-25-2018
16 Omnilife Science Inc. II Aug-21-2015
17 Signal Medical Corporation II Oct-22-2014
18 Smith & Nephew, Inc. II Mar-20-2019
19 Stryker Howmedica Osteonics Corp. II Jul-25-2016
20 Stryker Howmedica Osteonics Corp. II Nov-10-2015
21 Stryker Howmedica Osteonics Corp. II Sep-23-2015
22 Stryker Howmedica Osteonics Corp. II May-19-2015
23 Zimmer Biomet, Inc. II Nov-07-2019
24 Zimmer Biomet, Inc. II Jul-05-2018
25 Zimmer Biomet, Inc. II Apr-27-2018
26 Zimmer Biomet, Inc. II Mar-14-2018
27 Zimmer Biomet, Inc. II Mar-14-2018
28 Zimmer Biomet, Inc. II Mar-09-2018
29 Zimmer Biomet, Inc. II Feb-26-2018
30 Zimmer Biomet, Inc. II Jan-04-2018
31 Zimmer Biomet, Inc. II Mar-20-2017
32 Zimmer Biomet, Inc. II Jan-13-2017
33 Zimmer Biomet, Inc. II Mar-04-2016
34 Zimmer Biomet, Inc. II Feb-22-2016
35 Zimmer Gmbh II Feb-20-2015
36 Zimmer Inc. II Jun-26-2015
37 Zimmer Manufacturing B.V. II May-16-2016
38 Zimmer Manufacturing B.V. II Mar-12-2016
39 Zimmer Manufacturing B.V. II Dec-24-2014
40 Zimmer Manufacturing B.V. II Dec-17-2014
41 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
42 Zimmer, Inc. II Jul-10-2014
43 Zimmer, Inc. II Jun-20-2014
44 Zimmer, Inc. II Apr-24-2014
45 Zimmer, Inc. II Feb-20-2014

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