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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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 3
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 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 17
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
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 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
WALDEMAR LINK GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 2160 2160
2018 3115 3115
2019 3080 3080
2020 1952 1952
2021 2198 2198
2022 1166 1166

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2964 2964
Adverse Event Without Identified Device or Use Problem 2921 2921
Device Dislodged or Dislocated 2882 2882
Appropriate Term/Code Not Available 1320 1320
Fracture 795 795
Break 410 410
Loose or Intermittent Connection 397 397
Naturally Worn 303 303
Material Erosion 280 280
Corroded 273 273
Unstable 237 237
Loosening of Implant Not Related to Bone-Ingrowth 208 208
Osseointegration Problem 192 192
Noise, Audible 166 166
Migration or Expulsion of Device 145 145
Migration 124 124
Loss of Osseointegration 118 118
Inadequacy of Device Shape and/or Size 99 99
Malposition of Device 89 89
Difficult to Insert 74 74
Detachment of Device or Device Component 67 67
Device Slipped 65 65
Packaging Problem 60 60
Patient Device Interaction Problem 58 58
Patient-Device Incompatibility 58 58
Degraded 55 55
Mechanical Problem 54 54
Unintended Movement 54 54
Tear, Rip or Hole in Device Packaging 52 52
Metal Shedding Debris 50 50
Positioning Problem 48 48
Material Deformation 42 42
Crack 41 41
Material Integrity Problem 40 40
No Apparent Adverse Event 39 39
Use of Device Problem 39 39
Difficult to Remove 38 38
Fitting Problem 33 33
Material Disintegration 32 32
Biocompatibility 31 31
Loss of or Failure to Bond 29 29
Device Operates Differently Than Expected 28 28
Device Contaminated During Manufacture or Shipping 28 28
Device-Device Incompatibility 27 27
Scratched Material 26 26
Manufacturing, Packaging or Shipping Problem 24 24
Device Markings/Labelling Problem 23 23
Failure to Osseointegrate 21 21
Microbial Contamination of Device 21 21
Improper or Incorrect Procedure or Method 20 20
Material Fragmentation 20 20
Positioning Failure 19 19
Mechanical Jam 19 19
Device Contamination with Chemical or Other Material 17 17
Device Damaged Prior to Use 17 17
Disassembly 16 16
Failure To Adhere Or Bond 16 16
Material Separation 15 15
Separation Failure 14 14
Problem with Sterilization 13 13
Inaccurate Information 13 13
Difficult To Position 12 12
Off-Label Use 11 11
Device Damaged by Another Device 11 11
Output Problem 11 11
Unsealed Device Packaging 10 10
Contamination 10 10
Activation, Positioning or SeparationProblem 9 9
Difficult to Open or Remove Packaging Material 9 9
Deformation Due to Compressive Stress 8 8
Contamination /Decontamination Problem 8 8
Defective Device 8 8
Material Discolored 8 8
Misassembled 7 7
Component Missing 7 7
Physical Resistance/Sticking 7 7
Device Issue 6 6
Nonstandard Device 6 6
Separation Problem 6 6
Delivered as Unsterile Product 5 5
Component Incompatible 5 5
Failure to Align 5 5
Failure to Disconnect 5 5
Connection Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Compatibility Problem 5 5
Human-Device Interface Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Entrapment of Device 4 4
Incomplete or Missing Packaging 4 4
Material Perforation 3 3
Sticking 3 3
No Device Output 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Detachment Of Device Component 3 3
Disconnection 3 3
Difficult or Delayed Positioning 3 3
Device Handling Problem 3 3
Component or Accessory Incompatibility 3 3
Device Packaging Compromised 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2708 2708
Joint Dislocation 2371 2371
Unspecified Infection 2028 2028
No Code Available 2011 2011
No Information 1178 1178
Injury 1010 1010
Reaction 644 644
Bone Fracture(s) 554 554
No Clinical Signs, Symptoms or Conditions 514 514
Failure of Implant 465 465
Insufficient Information 439 439
Inadequate Osseointegration 417 417
No Known Impact Or Consequence To Patient 416 416
Joint Disorder 380 380
Inflammation 364 364
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 328 328
Tissue Damage 283 283
Not Applicable 270 270
Test Result 267 267
Discomfort 254 254
Fall 243 243
Osteolysis 236 236
Ambulation Difficulties 208 208
Foreign Body Reaction 207 207
No Consequences Or Impact To Patient 204 204
Joint Laxity 188 188
Limited Mobility Of The Implanted Joint 161 161
Loss of Range of Motion 161 161
Hip Fracture 156 156
Metal Related Pathology 143 143
Host-Tissue Reaction 134 134
Hematoma 121 121
Necrosis 114 114
Local Reaction 109 109
Swelling 101 101
Blood Loss 92 92
Impaired Healing 75 75
Hypersensitivity/Allergic reaction 70 70
Bacterial Infection 70 70
Ossification 69 69
Limb Fracture 69 69
Synovitis 65 65
Scar Tissue 55 55
Wound Dehiscence 53 53
Fluid Discharge 53 53
No Patient Involvement 47 47
Swelling/ Edema 44 44
Fatigue 44 44
Weakness 43 43
Adhesion(s) 40 40
Thrombosis 39 39
Edema 37 37
Pulmonary Embolism 34 34
Fever 32 32
Physical Asymmetry 32 32
Patient Problem/Medical Problem 32 32
Osteopenia/ Osteoporosis 31 31
Death 31 31
Cardiac Arrest 29 29
Unequal Limb Length 29 29
Post Operative Wound Infection 24 24
Muscular Rigidity 24 24
Infarction, Cerebral 23 23
Cyst(s) 23 23
Erythema 23 23
Muscle/Tendon Damage 23 23
Unspecified Tissue Injury 23 23
Foreign Body In Patient 21 22
Hemorrhage/Bleeding 21 21
Abscess 21 21
Deformity/ Disfigurement 20 20
Distress 20 20
Implant Pain 20 20
Anxiety 18 18
Nerve Damage 18 18
Anemia 17 17
Cellulitis 17 17
Toxicity 16 16
Depression 15 15
Thrombosis/Thrombus 14 14
Numbness 13 13
Urinary Retention 13 13
Myocardial Infarction 13 13
Arthralgia 12 12
Urinary Tract Infection 11 11
Granuloma 11 11
Hearing Impairment 10 10
Seroma 10 10
Subluxation 10 10
Device Embedded In Tissue or Plaque 10 10
Unspecified Musculoskeletal problem 9 9
Shaking/Tremors 9 9
Burning Sensation 9 9
Erosion 9 9
Stroke/CVA 8 8
Aspiration/Inhalation 8 8
Encephalopathy 8 8
Low Blood Pressure/ Hypotension 8 8
Muscle Weakness 8 8
Pneumonia 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-28-2020
2 Exactech, Inc. II Aug-12-2021
3 Exactech, Inc. II Jul-22-2021
4 Exactech, Inc. II Jan-17-2017
5 Howmedica Osteonics Corp. II Mar-31-2022
6 IMPLANTCAST GMBH II Jul-09-2021
7 IMPLANTCAST GMBH II Jul-20-2018
8 Medacta Usa Inc II Oct-19-2018
9 MicroPort Orthopedics Inc. II Jan-03-2017
10 OMNIlife science Inc. II Jan-26-2021
11 OMNIlife science Inc. II Sep-05-2019
12 Smith & Nephew Orthopaedics AG II Aug-19-2020
13 Smith & Nephew, Inc. II Aug-29-2017
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
15 Zimmer Biomet, Inc. II Nov-07-2019
16 Zimmer Biomet, Inc. II Apr-16-2018
17 Zimmer Biomet, Inc. II Mar-14-2018
18 Zimmer Biomet, Inc. II Dec-29-2017
19 Zimmer Biomet, Inc. II Mar-20-2017
20 Zimmer GmbH II Dec-20-2018
21 Zimmer GmbH II Apr-26-2018
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