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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 3445
Device Dislodged or Dislocated 2258
Adverse Event Without Identified Device or Use Problem 1303
Appropriate Term/Code Not Available 433
Fracture 381
Naturally Worn 237
Break 201
Corroded 198
Material Erosion 191
Migration or Expulsion of Device 163
Noise, Audible 137
Unstable 107
Loose or Intermittent Connection 95
Loss of Osseointegration 93
Metal Shedding Debris 78
Difficult to Insert 77
Malposition of device 67
Migration 53
Loosening of Implant Not Related to Bone-Ingrowth 49
Packaging Problem 46
Inadequacy of Device Shape and/or Size 36
Material Deformation 33
No Apparent Adverse Event 32
Material Integrity Problem 31
Mechanical Problem 30
Material Disintegration 29
Detachment of Device or device Component 29
Failure To Adhere Or Bond 28
Tear, Rip or Hole in Device Packaging 27
Positioning Problem 26
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 19
Detachment Of Device Component 18
Fitting Problem 17
Device Markings / Labelling Problem 17
Difficult To Position 17
Scratched Material 15
Device Slipped 14
Difficult to Remove 13
Material Fragmentation 13
Device Contaminated during manufacture or shipping 13
Unintended Movement 13
Device Operates Differently Than Expected 12
Problem with Sterilization 12
Material Discolored 11
Patient-Device Incompatibility 11
Material Separation 10
Manufacturing, Packaging or Shipping Problem 9
Device Damaged Prior to Use 8
Positioning Failure 8
Mechanical Jam 8
Compatibility Problem 8
Use of Device Problem 8
Device Issue 7
Device Damaged by Another Device 7
Separation Failure 7
Separation Problem 6
Defective Device 6
Misassembled 6
Component or Accessory Incompatibility 5
Patient Device Interaction Problem 5
Off-Label Use 5
Component Missing 5
Unsealed Device Packaging 4
Device Packaging Compromised 4
Improper or Incorrect Procedure or Method 4
Difficult to Open or Remove Packaging Material 4
Failure to Osseointegrate 4
Crack 4
Failure to Disconnect 4
Device Abrasion From Instrument Or Another Object 3
Screw 3
Retraction Problem 3
Contamination / decontamination Problem 3
Incomplete or Missing Packaging 2
Excessive Cooling 2
Mechanics Altered 2
Difficult or Delayed Separation 2
Human-Device Interface Problem 2
Difficult or Delayed Positioning 2
Disconnection 2
Ball 2
Collapse 2
Component Incompatible 2
Inaccurate Information 2
Sticking 2
Ambient Noise Problem 2
Partial Blockage 2
Device Expiration Issue 2
Delivered as Unsterile Product 2
Physical Resistance 1
Device Disinfection Or Sterilization Issue 1
Misconnection 1
Device Or Device Fragments Location Unknown 1
Dent in Material 1
Total Device Problems 10467

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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