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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 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 3
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 2
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 2
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 7
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 3117 3117
2019 3080 3080
2020 1952 1952
2021 2199 2199
2022 1830 1830

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3223 3223
Insufficient Information 3003 3003
Device Dislodged or Dislocated 2976 2976
Appropriate Term/Code Not Available 1339 1339
Fracture 856 856
Break 413 413
Loose or Intermittent Connection 399 399
Naturally Worn 314 314
Material Erosion 289 289
Corroded 284 284
Unstable 246 246
Osseointegration Problem 228 228
Loosening of Implant Not Related to Bone-Ingrowth 217 217
Noise, Audible 175 175
Migration or Expulsion of Device 149 149
Migration 138 138
Loss of Osseointegration 130 130
Inadequacy of Device Shape and/or Size 102 102
Malposition of Device 90 90
Difficult to Insert 77 77
Detachment of Device or Device Component 74 74
Patient Device Interaction Problem 71 71
Packaging Problem 68 68
Device Slipped 65 65
Degraded 63 63
Patient-Device Incompatibility 59 59
Tear, Rip or Hole in Device Packaging 58 58
Mechanical Problem 58 58
Unintended Movement 57 57
Positioning Problem 50 50
Metal Shedding Debris 50 50
Material Integrity Problem 46 46
Crack 43 43
Use of Device Problem 42 42
Material Deformation 42 42
No Apparent Adverse Event 42 42
Difficult to Remove 40 40
Biocompatibility 36 36
Fitting Problem 33 33
Material Disintegration 32 32
Loss of or Failure to Bond 30 30
Device Contaminated During Manufacture or Shipping 29 29
Scratched Material 28 28
Device Operates Differently Than Expected 28 28
Device-Device Incompatibility 27 27
Manufacturing, Packaging or Shipping Problem 26 26
Failure to Osseointegrate 26 26
Improper or Incorrect Procedure or Method 23 23
Device Markings/Labelling Problem 23 23
Positioning Failure 22 22
Microbial Contamination of Device 21 21
Material Fragmentation 20 20
Mechanical Jam 20 20
Inaccurate Information 20 20
Device Appears to Trigger Rejection 19 19
Device Damaged Prior to Use 17 17
Device Contamination with Chemical or Other Material 17 17
Separation Failure 16 16
Disassembly 16 16
Failure To Adhere Or Bond 16 16
Material Separation 15 15
Problem with Sterilization 13 13
Difficult To Position 12 12
Off-Label Use 11 11
Device Damaged by Another Device 11 11
Activation, Positioning or Separation Problem 11 11
Output Problem 11 11
Unsealed Device Packaging 10 10
Contamination 10 10
Difficult to Open or Remove Packaging Material 9 9
Contamination /Decontamination Problem 9 9
Physical Resistance/Sticking 9 9
Deformation Due to Compressive Stress 8 8
Defective Device 8 8
Material Discolored 8 8
Misassembled 7 7
Nonstandard Device 7 7
Component Missing 7 7
Delivered as Unsterile Product 6 6
Device Issue 6 6
Separation Problem 6 6
Failure to Align 5 5
Failure to Disconnect 5 5
Connection Problem 5 5
Human-Device Interface Problem 5 5
Compatibility Problem 5 5
Therapeutic or Diagnostic Output Failure 5 5
Labelling, Instructions for Use or Training Problem 5 5
Component Incompatible 5 5
Difficult or Delayed Positioning 4 4
Particulates 4 4
Entrapment of Device 4 4
Incomplete or Missing Packaging 4 4
Defective Component 4 4
Expiration Date Error 3 3
Component or Accessory Incompatibility 3 3
Device Packaging Compromised 3 3
Device Handling Problem 3 3
Material Perforation 3 3
Sticking 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2826 2826
Joint Dislocation 2502 2502
Unspecified Infection 2139 2139
No Code Available 2013 2013
No Information 1178 1178
Injury 1012 1012
Reaction 644 644
No Clinical Signs, Symptoms or Conditions 597 597
Bone Fracture(s) 585 585
Failure of Implant 512 512
Insufficient Information 484 484
Inadequate Osseointegration 462 462
No Known Impact Or Consequence To Patient 416 416
Joint Disorder 380 380
Inflammation 369 369
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 331 331
Tissue Damage 283 283
Not Applicable 270 270
Test Result 268 268
Discomfort 265 265
Fall 262 262
Osteolysis 246 246
Joint Laxity 231 231
Foreign Body Reaction 230 230
Ambulation Difficulties 221 221
No Consequences Or Impact To Patient 204 204
Metal Related Pathology 189 189
Loss of Range of Motion 180 180
Limited Mobility Of The Implanted Joint 162 162
Hip Fracture 159 159
Host-Tissue Reaction 134 134
Hematoma 124 124
Necrosis 118 118
Local Reaction 111 111
Swelling 101 101
Blood Loss 92 92
Limb Fracture 84 84
Impaired Healing 77 77
Hypersensitivity/Allergic reaction 73 73
Ossification 73 73
Bacterial Infection 70 70
Synovitis 68 68
Scar Tissue 63 63
Fluid Discharge 57 57
Wound Dehiscence 55 55
Swelling/ Edema 50 50
No Patient Involvement 47 47
Fatigue 47 47
Weakness 45 45
Adhesion(s) 43 43
Thrombosis 39 39
Physical Asymmetry 39 39
Edema 38 38
Osteopenia/ Osteoporosis 35 35
Unequal Limb Length 34 34
Pulmonary Embolism 34 34
Fever 33 33
Patient Problem/Medical Problem 32 32
Unspecified Tissue Injury 31 31
Death 31 31
Cardiac Arrest 29 29
Muscle/Tendon Damage 28 28
Implant Pain 27 27
Muscular Rigidity 27 27
Distress 26 26
Erythema 25 25
Foreign Body In Patient 25 26
Post Operative Wound Infection 24 24
Deformity/ Disfigurement 24 24
Cyst(s) 23 23
Hemorrhage/Bleeding 23 23
Infarction, Cerebral 23 23
Abscess 22 22
Anxiety 19 19
Nerve Damage 18 18
Anemia 17 17
Cellulitis 17 17
Thrombosis/Thrombus 17 17
Toxicity 16 16
Depression 16 16
Myocardial Infarction 14 14
Arthralgia 13 13
Urinary Retention 13 13
Numbness 13 13
Subluxation 12 12
Unspecified Musculoskeletal problem 11 11
Urinary Tract Infection 11 11
Seroma 11 11
Granuloma 11 11
Hearing Impairment 10 10
Device Embedded In Tissue or Plaque 10 10
Embolism/Embolus 9 9
Shaking/Tremors 9 9
Erosion 9 9
Pneumonia 9 9
Burning Sensation 9 9
Dizziness 8 8
Muscle Weakness 8 8
Stroke/CVA 8 8
Aspiration/Inhalation 8 8

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