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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
Product CodeLZO
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP IMPLANTS SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 5
CORIN USA
  SUBSTANTIALLY EQUIVALENT 14
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 6
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY FRANCE S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
DEPUY ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 9
GLOBAL MANUFACTURING TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ICONACY ORTHOPEDIC IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 3
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 3
KYOCERA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 8
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 10
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 4
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 8
MICROPORT ORTHOPEDICS INC. (MPO)
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 3
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
OTIS BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 4
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
TGM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 8
WALDEMAR LINK GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 7
XERXES ARTHOPEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2014 1467 1467
2015 1343 1343
2016 1727 1727
2017 2159 2159
2018 3127 3127
2019 3074 3074
2020 1956 1956
2021 2200 2200
2022 1985 1985
2023 2068 2093
2024 590 590

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4728 4728
Adverse Event Without Identified Device or Use Problem 4710 4735
Device Dislodged or Dislocated 4341 4341
Appropriate Term/Code Not Available 1676 1676
Fracture 1384 1384
Break 622 622
Loose or Intermittent Connection 570 570
Naturally Worn 548 548
Osseointegration Problem 406 406
Corroded 353 353
Material Erosion 347 347
Unstable 342 342
Noise, Audible 300 300
Loosening of Implant Not Related to Bone-Ingrowth 269 269
Migration or Expulsion of Device 218 218
Loss of Osseointegration 213 213
Migration 199 199
Device Slipped 191 191
Metal Shedding Debris 171 171
Malposition of Device 157 157
Difficult to Insert 154 154
Inadequacy of Device Shape and/or Size 152 152
Patient Device Interaction Problem 116 116
Device Operates Differently Than Expected 112 112
Tear, Rip or Hole in Device Packaging 109 109
Packaging Problem 103 103
Detachment of Device or Device Component 102 102
Patient-Device Incompatibility 97 97
Device Appears to Trigger Rejection 90 90
Material Integrity Problem 85 85
Degraded 82 82
Mechanical Problem 81 81
Positioning Problem 79 79
Failure To Adhere Or Bond 75 75
Manufacturing, Packaging or Shipping Problem 75 75
Fitting Problem 67 67
Failure to Osseointegrate 66 66
Unintended Movement 66 66
Crack 63 63
Difficult to Remove 62 62
No Apparent Adverse Event 61 61
Material Deformation 56 56
Use of Device Problem 52 52
Nonstandard Device 51 51
Improper or Incorrect Procedure or Method 50 50
Device Contaminated During Manufacture or Shipping 49 49
Scratched Material 48 48
Biocompatibility 45 45
Loss of or Failure to Bond 45 45
Device-Device Incompatibility 43 43
Material Disintegration 38 38
Device Markings/Labelling Problem 37 37
Device Contamination with Chemical or Other Material 37 37
Material Fragmentation 35 35
Disassembly 29 29
Material Separation 28 28
Mechanical Jam 26 26
Microbial Contamination of Device 25 25
Positioning Failure 25 25
Detachment Of Device Component 23 23
Off-Label Use 22 22
Difficult To Position 20 20
Device Damaged Prior to Use 19 19
Inaccurate Information 19 19
Separation Failure 18 18
Material Discolored 18 18
Contamination 15 15
Compatibility Problem 15 15
Connection Problem 14 14
Activation, Positioning or Separation Problem 14 14
Defective Device 13 13
Failure to Align 13 13
Problem with Sterilization 13 13
Wrong Label 13 13
Delivered as Unsterile Product 12 12
Device Damaged by Another Device 12 12
Device Packaging Compromised 12 12
Material Protrusion/Extrusion 11 11
Contamination /Decontamination Problem 11 11
Output Problem 10 10
Difficult to Open or Remove Packaging Material 10 10
Unsealed Device Packaging 10 10
Physical Resistance/Sticking 10 10
Sticking 9 9
Failure to Disconnect 9 9
Component Missing 9 9
Component or Accessory Incompatibility 8 8
Deformation Due to Compressive Stress 8 8
Labelling, Instructions for Use or Training Problem 8 8
Separation Problem 8 8
Component Incompatible 7 7
Misassembled 7 7
Defective Component 7 7
Device Issue 7 7
Incomplete or Missing Packaging 6 6
Human-Device Interface Problem 6 6
Entrapment of Device 6 6
Device Expiration Issue 5 5
Mechanics Altered 5 5
Expiration Date Error 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4517 4517
Unspecified Infection 3399 3422
Joint Dislocation 3193 3193
No Code Available 2928 2928
No Information 2095 2095
Injury 1230 1230
Bone Fracture(s) 946 948
No Clinical Signs, Symptoms or Conditions 918 918
Failure of Implant 814 814
Insufficient Information 767 767
Reaction 742 742
Inadequate Osseointegration 657 657
No Known Impact Or Consequence To Patient 594 594
Inflammation 489 489
Fall 479 479
Osteolysis 418 418
Joint Disorder 413 413
Ambulation Difficulties 401 401
Discomfort 390 390
Tissue Damage 385 385
Joint Laxity 381 381
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 379 379
Foreign Body Reaction 362 362
Loss of Range of Motion 319 319
Test Result 318 318
Metal Related Pathology 311 311
No Consequences Or Impact To Patient 291 291
Not Applicable 288 288
Limited Mobility Of The Implanted Joint 234 234
Toxicity 216 216
Host-Tissue Reaction 205 205
Hip Fracture 197 197
Swelling 194 194
Hematoma 173 173
Necrosis 161 161
Limb Fracture 158 158
Local Reaction 118 118
Hypersensitivity/Allergic reaction 108 108
Ossification 107 107
Bacterial Infection 99 99
Scar Tissue 98 98
Blood Loss 92 92
Impaired Healing 90 90
Swelling/ Edema 87 87
Fluid Discharge 86 86
Synovitis 86 86
Implant Pain 84 84
Physical Asymmetry 70 70
Wound Dehiscence 70 70
Fatigue 67 67
Unspecified Tissue Injury 63 63
Adhesion(s) 57 57
Weakness 56 56
Osteopenia/ Osteoporosis 56 56
Unequal Limb Length 55 55
Muscle/Tendon Damage 54 54
No Patient Involvement 54 54
Cyst(s) 48 48
Distress 45 45
Edema 43 43
Muscular Rigidity 43 43
Thrombosis 40 40
Fever 40 40
Pulmonary Embolism 40 40
Complaint, Ill-Defined 40 40
Death 36 36
Erythema 35 35
Hemorrhage/Bleeding 35 35
Deformity/ Disfigurement 35 35
Foreign Body In Patient 35 36
Patient Problem/Medical Problem 33 33
Thrombosis/Thrombus 33 33
Post Operative Wound Infection 31 31
Cardiac Arrest 31 31
Abscess 30 30
Nerve Damage 30 30
Subluxation 27 27
Numbness 26 26
Disability 25 25
Arthralgia 23 23
Anxiety 23 23
Seroma 23 23
Infarction, Cerebral 23 23
Device Embedded In Tissue or Plaque 22 22
Depression 20 20
Cellulitis 19 19
Rash 19 19
Myocardial Infarction 18 18
Anemia 17 17
Hearing Impairment 16 16
Nausea 16 16
Muscle Weakness 15 15
Sepsis 15 15
Unspecified Musculoskeletal problem 15 15
Fibrosis 13 13
Sleep Dysfunction 13 13
Urinary Retention 13 13
Headache 13 13
Granuloma 12 12
Erosion 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Aug-12-2011
2 Biomet, Inc. II Dec-18-2023
3 Biomet, Inc. II May-28-2020
4 Biomet, Inc. II Jan-13-2016
5 Biomet, Inc. II Apr-23-2012
6 Biomet, Inc. II Mar-02-2012
7 Biomet, Inc. II Jul-14-2009
8 Corin Ltd II Dec-19-2022
9 Corin USA Limited II Apr-22-2016
10 DePuy Orthopaedics, Inc. II Dec-17-2014
11 Encore Medical, LP II Sep-19-2023
12 Exactech, Inc. II Sep-09-2022
13 Exactech, Inc. II Aug-12-2021
14 Exactech, Inc. II Jul-22-2021
15 Exactech, Inc. II Jan-17-2017
16 Exactech, Inc. II Jul-05-2016
17 Exactech, Inc. II Jul-21-2014
18 Exactech, Inc. II Feb-05-2013
19 Howmedica Osteonics Corp. II Mar-31-2022
20 IMPLANTCAST GMBH II Jul-09-2021
21 IMPLANTCAST GMBH II Jul-20-2018
22 Medacta Usa Inc II Oct-19-2018
23 MicroPort Orthopedics Inc. II Jan-03-2017
24 MicroPort Orthopedics Inc. III Dec-01-2016
25 OMNIlife science Inc. II Jan-26-2021
26 OMNIlife science Inc. II Sep-05-2019
27 Omnilife Science Inc. II Jul-14-2015
28 Omnilife Science Inc. II Aug-15-2014
29 Ortho Development Corporation II Jan-13-2012
30 Ortho Development Corporation II Mar-16-2011
31 Orthopedic Alliance LLC II May-24-2013
32 Smith & Nephew Orthopaedics AG II Aug-19-2020
33 Smith & Nephew, Inc. II Aug-29-2017
34 Stryker Howmedica Osteonics Corp. II Sep-28-2012
35 Stryker Howmedica Osteonics Corp. II Nov-16-2011
36 Stryker Howmedica Osteonics Corp. II Mar-11-2010
37 Stryker Howmedica Osteonics Corp. II Jan-11-2010
38 Stryker Howmedica Osteonics Corp. III Sep-14-2009
39 Stryker Howmedica Osteonics Corp. II May-21-2009
40 Stryker Howmedica Osteonics Corp. II Jan-26-2009
41 Stryker Howmedica Osteonics Corp. II Jan-26-2009
42 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
43 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
44 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
45 Zimmer Biomet, Inc. II Nov-07-2019
46 Zimmer Biomet, Inc. II Apr-16-2018
47 Zimmer Biomet, Inc. II Mar-14-2018
48 Zimmer Biomet, Inc. II Dec-29-2017
49 Zimmer Biomet, Inc. II Mar-20-2017
50 Zimmer GmbH II Dec-20-2018
51 Zimmer GmbH II Apr-26-2018
52 Zimmer Gmbh II Jul-26-2016
53 Zimmer Gmbh II Feb-20-2015
54 Zimmer Inc. II Jul-27-2009
55 Zimmer, Inc. II Feb-27-2015
56 Zimmer, Inc. II Nov-06-2012
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