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


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
ICONACY
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST
  SUBSTANTIALLY EQUIVALENT 2
KYOCERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 5
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 13
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 5
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNI
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
TGM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 13

Device Problems
Insufficient Information 3458
Device Dislodged or Dislocated 2311
Adverse Event Without Identified Device or Use Problem 1366
Appropriate Term/Code Not Available 439
Fracture 397
Naturally Worn 239
Break 216
Corroded 208
Material Erosion 202
Migration or Expulsion of Device 163
Noise, Audible 138
Unstable 107
Loss of Osseointegration 98
Loose or Intermittent Connection 96
Metal Shedding Debris 78
Difficult to Insert 77
Malposition of device 68
Migration 53
Loosening of Implant Not Related to Bone-Ingrowth 51
Packaging Problem 47
Inadequacy of Device Shape and/or Size 39
No Apparent Adverse Event 34
Material Deformation 33
Material Integrity Problem 31
Mechanical Problem 30
Detachment of Device or device Component 30
Failure To Adhere Or Bond 28
Tear, Rip or Hole in Device Packaging 28
Positioning Problem 27
Material Disintegration 27
Disassembly 26
Degraded 26
Biocompatibility 24
Device-Device Incompatibility 24
Device Contamination with Chemical or Other Material 23
Osseointegration Problem 21
Loss of or Failure to Bond 20
Detachment Of Device Component 18
Scratched Material 18
Difficult To Position 17
Fitting Problem 17
Device Markings / Labelling Problem 16
Material Fragmentation 14
Device Slipped 14
Unintended Movement 14
Device Contaminated during manufacture or shipping 13
Difficult to Remove 13
Manufacturing, Packaging or Shipping Problem 13
Problem with Sterilization 12
Device Operates Differently Than Expected 12
Material Discolored 11
Patient-Device Incompatibility 11
Material Separation 10
Compatibility Problem 9
Use of Device Problem 8
Mechanical Jam 8
Device Damaged Prior to Use 8
Positioning Failure 8
Separation Failure 7
Device Damaged by Another Device 7
Device Issue 7
Misassembled 6
Patient Device Interaction Problem 6
Defective Device 6
Separation Problem 6
Difficult to Open or Remove Packaging Material 5
Off-Label Use 5
Component Missing 5
Component or Accessory Incompatibility 5
Failure to Osseointegrate 4
Crack 4
Failure to Disconnect 4
Unsealed Device Packaging 4
Device Packaging Compromised 4
Contamination / decontamination Problem 4
Connection Problem 4
Improper or Incorrect Procedure or Method 4
Device Abrasion From Instrument Or Another Object 3
Screw 3
Retraction Problem 3
Component Incompatible 2
Inaccurate Information 2
Sticking 2
Ambient Noise Problem 2
Partial Blockage 2
Device Expiration Issue 2
Delivered as Unsterile Product 2
Incomplete or Missing Packaging 2
Excessive Cooling 2
Mechanics Altered 2
Difficult or Delayed Separation 2
Defective Component 2
No Device Output 2
Difficult or Delayed Positioning 2
Disconnection 2
Ball 2
Collapse 2
Human-Device Interface Problem 2
Thread 1
Missing Information 1
Total Device Problems 10691

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-28-2020
2 Biomet, Inc. II Jan-13-2016
3 Corin USA Limited II Apr-22-2016
4 Exactech, Inc. II Jan-17-2017
5 Exactech, Inc. II Jul-05-2016
6 IMPLANTCAST GMBH II Jul-20-2018
7 Medacta Usa Inc II Oct-19-2018
8 MicroPort Orthopedics Inc. II Jan-03-2017
9 MicroPort Orthopedics Inc. III Dec-01-2016
10 OMNIlife science Inc. II Sep-05-2019
11 Omnilife Science Inc. II Jul-14-2015
12 Smith & Nephew, Inc. II Aug-29-2017
13 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
14 Zimmer Biomet, Inc. II Nov-07-2019
15 Zimmer Biomet, Inc. II Apr-16-2018
16 Zimmer Biomet, Inc. II Mar-14-2018
17 Zimmer Biomet, Inc. II Dec-29-2017
18 Zimmer Biomet, Inc. II Mar-20-2017
19 Zimmer GmbH II Dec-20-2018
20 Zimmer GmbH II Apr-26-2018
21 Zimmer Gmbh II Jul-26-2016
22 Zimmer Gmbh II Feb-20-2015
23 Zimmer, Inc. II Feb-27-2015

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