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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 IMPLANTS SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 5
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 5
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY FRANCE S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
ICONACY ORTHOPEDIC IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 16
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROPORT ORTHOPEDICS INC. (MPO)
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 1726 1726
2017 2160 2160
2018 3114 3114
2019 3077 3077
2020 1948 1948
2021 1825 1825

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3525 3525
Device Dislodged or Dislocated 3021 3021
Adverse Event Without Identified Device or Use Problem 2464 2464
Appropriate Term/Code Not Available 1248 1248
Fracture 775 775
Loose or Intermittent Connection 443 443
Break 386 386
Naturally Worn 307 307
Corroded 273 273
Material Erosion 266 266
Unstable 236 236
Noise, Audible 196 196
Migration or Expulsion of Device 174 174
Loosening of Implant Not Related to Bone-Ingrowth 168 168
Osseointegration Problem 125 125
Loss of Osseointegration 115 115
Inadequacy of Device Shape and/or Size 107 107
Migration 100 100
Malposition of Device 99 99
Device Slipped 94 94
Difficult to Insert 84 84
Metal Shedding Debris 74 74
Patient-Device Incompatibility 60 60
Device Operates Differently Than Expected 53 53
Packaging Problem 53 53
Detachment of Device or Device Component 51 51
Positioning Problem 49 49
Mechanical Problem 47 47
Material Deformation 44 44
Failure To Adhere Or Bond 44 44
Unintended Movement 43 43
Tear, Rip or Hole in Device Packaging 42 42
Fitting Problem 41 41
Difficult to Remove 39 39
Degraded 39 39
No Apparent Adverse Event 39 39
Crack 37 37
Material Disintegration 35 35
Use of Device Problem 33 33
Device-Device Incompatibility 33 33
Device Markings/Labelling Problem 32 32
Loss of or Failure to Bond 31 31
Material Integrity Problem 30 30
Biocompatibility 30 30
Scratched Material 27 27
Device Contamination with Chemical or Other Material 27 27
Patient Device Interaction Problem 27 27
Microbial Contamination of Device 25 25
Disassembly 25 25
Improper or Incorrect Procedure or Method 23 23
Material Fragmentation 22 22
Device Contaminated During Manufacture or Shipping 22 22
Manufacturing, Packaging or Shipping Problem 19 19
Positioning Failure 18 18
Material Separation 17 17
Mechanical Jam 17 17
Device Damaged Prior to Use 17 17
Difficult To Position 17 17
Failure to Osseointegrate 16 16
Separation Failure 14 14
Problem with Sterilization 13 13
Contamination 13 13
Detachment Of Device Component 12 12
Material Discolored 10 10
Compatibility Problem 10 10
Connection Problem 9 9
Unsealed Device Packaging 9 9
Off-Label Use 9 9
Defective Device 9 9
Device Damaged by Another Device 8 8
Device Packaging Compromised 8 8
Contamination /Decontamination Problem 8 8
Misassembled 7 7
Delivered as Unsterile Product 7 7
Material Protrusion/Extrusion 7 7
Difficult to Open or Remove Packaging Material 7 7
Separation Problem 6 6
Inaccurate Information 6 6
Device Issue 6 6
Component Incompatible 6 6
Component Missing 6 6
Deformation Due to Compressive Stress 6 6
Component or Accessory Incompatibility 5 5
Nonstandard Device 5 5
Failure to Disconnect 5 5
Entrapment of Device 4 4
Device Expiration Issue 4 4
Failure to Align 4 4
Labelling, Instructions for Use or Training Problem 4 4
Output Problem 4 4
Defective Component 4 4
Device Appears to Trigger Rejection 3 3
Retraction Problem 3 3
Difficult or Delayed Separation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Difficult or Delayed Positioning 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Material Perforation 3 3
No Device Output 3 3
Disconnection 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2871 2871
Joint Dislocation 2289 2289
No Code Available 2281 2281
Unspecified Infection 2053 2053
No Information 1560 1560
Injury 1160 1160
Reaction 687 687
Bone Fracture(s) 544 544
No Known Impact Or Consequence To Patient 483 483
Joint Disorder 409 409
Failure of Implant 382 382
Inflammation 355 355
Inadequate Osseointegration 319 319
Tissue Damage 291 291
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 291 291
Not Applicable 282 282
Discomfort 279 279
Test Result 270 270
Insufficient Information 269 269
No Clinical Signs, Symptoms or Conditions 263 263
Osteolysis 248 248
No Consequences Or Impact To Patient 232 232
Fall 225 225
Foreign Body Reaction 216 216
Ambulation Difficulties 195 195
Limited Mobility Of The Implanted Joint 187 187
Host-Tissue Reaction 163 163
Loss of Range of Motion 143 143
Hip Fracture 140 140
Necrosis 121 121
Hematoma 121 121
Swelling 110 110
Local Reaction 104 104
Joint Laxity 100 100
Blood Loss 92 92
Metal Related Pathology 89 89
Impaired Healing 73 73
Hypersensitivity/Allergic reaction 69 69
Ossification 66 66
Synovitis 65 65
Bacterial Infection 63 63
Wound Dehiscence 53 53
Scar Tissue 53 53
No Patient Involvement 51 51
Weakness 48 48
Fatigue 42 42
Thrombosis 39 39
Edema 39 39
Death 34 34
Adhesion(s) 34 34
Limb Fracture 34 34
Patient Problem/Medical Problem 33 33
Fluid Discharge 31 31
Cardiac Arrest 30 30
Pulmonary Embolism 30 30
Toxicity 28 28
Muscular Rigidity 27 27
Cyst(s) 25 25
Swelling/ Edema 25 25
Infarction, Cerebral 23 23
Post Operative Wound Infection 23 23
Foreign Body In Patient 22 23
Physical Asymmetry 22 22
Osteopenia/ Osteoporosis 22 22
Abscess 22 22
Distress 21 21
Nerve Damage 20 20
Fever 20 20
Anxiety 19 19
Cellulitis 18 18
Deformity/ Disfigurement 17 17
Depression 17 17
Muscle/Tendon Damage 16 16
Hemorrhage/Bleeding 15 15
Unequal Limb Length 14 14
Unspecified Tissue Injury 14 14
Urinary Retention 13 13
Thrombosis/Thrombus 13 13
Numbness 13 13
Myocardial Infarction 13 13
Anemia 12 12
Seroma 11 11
Urinary Tract Infection 11 11
Device Embedded In Tissue or Plaque 11 11
Granuloma 10 10
Hearing Impairment 10 10
Burning Sensation 10 10
Implant Pain 10 10
Arthralgia 9 9
Sepsis 9 9
Muscle Weakness 9 9
Shaking/Tremors 9 9
Pneumonia 8 8
Encephalopathy 8 8
Joint Swelling 8 8
Low Blood Pressure/ Hypotension 8 8
Sleep Dysfunction 8 8
Complaint, Ill-Defined 8 8
Fibrosis 8 8
Aspiration/Inhalation 8 8

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 Aug-12-2021
5 Exactech, Inc. II Jul-22-2021
6 Exactech, Inc. II Jan-17-2017
7 Exactech, Inc. II Jul-05-2016
8 IMPLANTCAST GMBH II Jul-09-2021
9 IMPLANTCAST GMBH II Jul-20-2018
10 Medacta Usa Inc II Oct-19-2018
11 MicroPort Orthopedics Inc. II Jan-03-2017
12 MicroPort Orthopedics Inc. III Dec-01-2016
13 OMNIlife science Inc. II Jan-26-2021
14 OMNIlife science Inc. II Sep-05-2019
15 Smith & Nephew Orthopaedics AG II Aug-19-2020
16 Smith & Nephew, Inc. II Aug-29-2017
17 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
18 Zimmer Biomet, Inc. II Nov-07-2019
19 Zimmer Biomet, Inc. II Apr-16-2018
20 Zimmer Biomet, Inc. II Mar-14-2018
21 Zimmer Biomet, Inc. II Dec-29-2017
22 Zimmer Biomet, Inc. II Mar-20-2017
23 Zimmer GmbH II Dec-20-2018
24 Zimmer GmbH II Apr-26-2018
25 Zimmer Gmbh II Jul-26-2016
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